Ambler Surgical

Hajek-Kofler sphenoid punch forceps, 9 1/2'', working length 150mm, 360 degrees rotatable, angled 90 degrees, 3.0mm x 7.0mm jaws, with fixation nut, squeeze handle

Registry build 21.09.26
2manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code KTF
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Ambler Surgical
Listed by Ambler Surgical, LLC, United States
FDA product code KTF
Device type Punch, Ent
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2021-01-07
Record revised 2022-06-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Ambler Surgical
Catalogue number Size Status
Stammberger circular cutting punch forceps In distribution
Blakesley nasal cutting forceps In distribution
Giraffe punch forceps In distribution
Antrum punch forceps In distribution
Ostium sinus chain forceps In distribution
Blakesley nasal cutting forceps In distribution
Willaminski antrum perforator In distribution
Blakesley nasal cutting forceps In distribution
Antrum punch forceps In distribution
Blakesley nasal cutting forceps In distribution
Carley micro backbiting punch forceps In distribution
Ambler punch forceps In distribution
Hajek-Kofler sphenoid punch forceps In distribution
Bishop antrum perforator In distribution
McKenty sphenoid punch forceps In distribution
Ostium sinus chain forceps In distribution
Stammberger circular cutting punch forceps In distribution
Ostium sinus chain forceps In distribution
Brooks adenoid punch forceps In distribution
Hajek-Kofler sphenoid punch forceps In distribution
Stammberger circular cutting punch forceps In distribution
Blakesley nasal cutting forceps In distribution
Blakesley nasal cutting forceps In distribution
Carley micro backbiting punch forceps In distribution
Blakesley nasal cutting forceps In distribution
Blakesley nasal cutting forceps In distribution
Ambler punch forceps In distribution
Antrum punch forceps In distribution
Stammberger circular cutting punch forceps In distribution
Antrum punch forceps In distribution
Giraffe punch forceps In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
V. Mueller Steris Corporation 25
Boss Instruments Boss Instruments, Ltd. 22
Millennium Avalign Technologies, Inc. 20
MSI Precision Specialty Instruments MED Saver, Inc. 14
Aesculap Aesculap AG 8
Pilling Teleflex Medical LLC 7
Integra® Jarit® Integra LifeSciences Production Corporation 6
Avalign Avalign Technologies, Inc. 5
Antrum Punch Rongeur Sontec Instruments, Inc. 5
Symmetry Surgical Aspen Surgical Products, Inc. 5
Punch Rongeur Sontec Instruments, Inc. 4
Keyes Dermal Punch Sontec Instruments, Inc. 4

Showing 12 of 31. All products under Punch, Ent

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer