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Ambler Surgical

FDA UDI

Class II (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Hysterectomy forceps, reusable FDA UDI
Device Name
Z-Type hysterectomy (Parametrium) clamp forceps, 14", angled, serrated jaws, offset ring handle FDA UDI
Model / Reference
34-368 FDA UDI
Description
Z-Type hysterectomy (Parametrium) clamp forceps, 14", angled, serrated jaws, offset ring handle FDA UDI

Identifiers

Catalog Number
34-368 FDA UDI
Primary DI / UDI-DI
00190660080051 FDA UDI
510(k) Number
K092840 FDA UDI
FDA Product Code
HCZ FDA UDI
GMDN Term
Hysterectomy forceps, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 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

No

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: Hysterectomy forceps, reusable

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

Similar devices

Also classified as Hysterectomy forceps, reusable.

Cleared under the same submission

K092840 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 2b6e997f-5a67-4930-9c3e-cdef2a43b11d 36 fields · synced Jun 1, 2026