AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094080384)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901074
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36103
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094080384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Welch Allyn 6.0 V Illumination System for Disposable Endoscopes; Insufflation Bulb (#30200), Fiber-Optic Light Head (#36019), Light Handle with 3.0 ft/0.9 m Cord (#73211), Power Transformer with 5.0 ft/1.2 m Cord; 120 V, 60 Hz AC, IEC Plug Type-B

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?
15058	Rigid optical sigmoidoscope, reusable	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAM	sigmoidoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K770291	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 3d6ff656-f723-4b49-900d-871466a38ae5
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: April 26, 2021