Wallach

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: WALLACH FDA UDI
Generic Name: Colposcope FDA UDI
Device Name: ZoomScope® with Trulight Colposcope with 5-legged base FDA UDI
Model / Reference: 906043-SP-5 FDA UDI
Description: ZoomScope® with Trulight Colposcope with 5-legged base FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937013689 FDA UDI
510(k) Number: K853389 FDA UDI
FDA Product Code: HEX FDA UDI
GMDN Term: Colposcope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1630 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Colposcope

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

Similar devices

Also classified as Colposcope.

MICROSCOPE Colposcope — Ecleris · Class II
Bovie — BOVIE MEDICAL CORPORATION · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
MICROSTAR Colposcope — Ecleris · Class II
Gynex — GYNEX CORPORATION · Class II
MICROSCOPE Colposcope — Ecleris · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
Galileo Colposcope, Direct Access — GYNEX CORPORATION · Class II

Cleared under the same submission

K853389 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI 89a28d90-f1a3-42e5-9d81-62c94d94b083 34 fields · synced Jun 9, 2026