Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094080384
• Version / Model: 901074
• Catalog Number: 36103
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-26
• Public Version: 2
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 3d6ff656-f723-4b49-900d-871466a38ae5

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAM	sigmoidoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094080384	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K770291	000