AccessGUDID - DEVICE: NA (03596010645524)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 72201635S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72201635S
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010645524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: COUPLER, HIGH DEFINITION, NON-AUTOCLAVABLE, 19.5 MM, BLACK RING, SERVICE REPLACEMENT

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36292	Endoscope camera adaptor	An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEI	INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf1b32f4-7bd0-457b-af33-285dca8a44c8
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: September 28, 2015