Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name: Welch Allyn, Inc. FDA UDI
Generic Name: Rigid optical sigmoidoscope, reusable FDA UDI
Device Name: Welch Allyn 6.0 V Halogen Fiber-Optic Sigmoidoscope Set including Three Fiber-Optic Rigid Sigmoidoscopes with Obturators (#32410 15 mm x 15 cm, #32820 19 mm x 25 cm, #37023 23 mm x 7 cm), 30 cm Suction Tube (#30130), 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, Two Halogen Replacement Lamps (#07800-U), Hard Storage Case (#05391-U); 230 V, 50 Hz AC, IEC Plug Type-E/F FDA UDI
Model / Reference: 901075 FDA UDI
Description: Welch Allyn 6.0 V Halogen Fiber-Optic Sigmoidoscope Set including Three Fiber-Optic Rigid Sigmoidoscopes with Obturators (#32410 15 mm x 15 cm, #32820 19 mm x 25 cm, #37023 23 mm x 7 cm), 30 cm Suction Tube (#30130), 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, Two Halogen Replacement Lamps (#07800-U), Hard Storage Case (#05391-U); 230 V, 50 Hz AC, IEC Plug Type-E/F FDA UDI

Identifiers

Catalog Number: 35323 FDA UDI
Primary DI / UDI-DI: 00732094080612 FDA UDI
510(k) Number: K770291 FDA UDI
FDA Product Code: DLX FDA UDI
GMDN Term: Rigid optical sigmoidoscope, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Rigid optical sigmoidoscope, reusable

Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K770291 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Welch Allyn, Inc.

Sources (1)

FDA UDI 7262e56c-c279-4a06-b51d-991e1cbf9f7c 36 fields · synced May 31, 2026