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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
Laparoscopic tissue manipulation forceps/working-channel FDA UDI
Device Name
Prestige grasping forceps, rotatable, single-action, 5.0mm diameter, 330.0mm working length, atraumatic, wave shaped, straight tips, lateral serrated jaws, Prestige ring handle with slide lock FDA UDI
Model / Reference
Prestige grasping forceps FDA UDI
Description
Prestige grasping forceps, rotatable, single-action, 5.0mm diameter, 330.0mm working length, atraumatic, wave shaped, straight tips, lateral serrated jaws, Prestige ring handle with slide lock FDA UDI

Identifiers

Catalog Number
97-422 FDA UDI
Primary DI / UDI-DI
00190660205102 FDA UDI
FDA Product Code
GEN FDA UDI
GMDN Term
Laparoscopic tissue manipulation forceps/working-channel 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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: Laparoscopic tissue manipulation forceps/working-channel

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

Similar devices

Also classified as Laparoscopic tissue manipulation forceps/working-channel.

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 62380987-9197-4258-8211-5b9b4a194e92 35 fields · synced May 30, 2026