single-use device means a device that is intended to be used on an individual patient during a single procedure.
single-use device means a device that is intended to be used on one individual during a single procedure;
single-use device means a device that is intended to be used during a single procedure;
More Definitions of single-use device
single-use device means a medical device that is intended for 1 use or procedure on a human patient, including any device marked "single-use device".
single-use device means a device intended to be used once only for a single patient.
single-use device means a device that is intended to be used on an individual patient during a single procedure. (8) 'single-use device' means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse.
single-use device means a device intended for one use on a single patient during a single procedure.
single-use device means a device that is intended for one use on a single patient during a single
single-use device means a device that is intended for one use, or on a single patient during a single procedure. Section 201(ll) of the FD&C Act (21 U.S.C. 321(ll)). FDA interprets 21 CFR 801.45(d)(3) to mean that the UDI direct marking requirements do not apply to a device that the original labeler (as defined in 21 CFR 801.3) intends for one use, or use on a single patient during a single procedure, even if, subsequent to its initial use, the device is subjected to additional processing and manufacturing for the purpose of an additional single use on another patient. However, such reuse of a single-use device would generally require additional clearance or approval unless 510(k)-exempt,5 as well as compliance with general UDI labeling and GUDID data submission requirements by the entity performing the additional processing and manufacturing for the purpose of an additional single use. In contrast, for purposes of UDI direct marking requirements under 21 CFR 801.45, a device intended for repeated use on or by different patients is “intended to be
single-use device means a device that is intended to be used during a single procedure; (10)‘falsified device’ means any device with a false presentation of its identity and/or of its