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Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Uterine manipulator, reusable FDA UDI
Device Name
Cohen acorn uterine manipulator, 14 1/2'', includes 1 small and 1 large cervical cones FDA UDI
Model / Reference
Cohen acorn uterine manipulator FDA UDI
Description
Cohen acorn uterine manipulator, 14 1/2'', includes 1 small and 1 large cervical cones FDA UDI

Identifiers

Catalog Number
44-505 FDA UDI
Primary DI / UDI-DI
00190660101213 FDA UDI
510(k) Number
K060233 FDA UDI
FDA Product Code
GDJ FDA UDI
GMDN Term
Uterine manipulator, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Uterine manipulator, reusable

Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uterine manipulator, reusable.

Cleared under the same submission

K060233 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambler Surgical, LLC

Sources (1)

  • FDA UDI 6ec38ac1-9dbb-45d0-848e-393b7b10014a 36 fields · synced May 31, 2026