Ambler Surgical

Ferris-Smith laminectomy kerrison rongeur, 10 1/2'', working length 210mm, angled 90 degrees down, 4.0mm x 4.0mm bite, finger grip handle

Registry build 21.09.26
3manufacturers in China registered for this device type
16catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KBB
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
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 KBB
Device type Rongeur, Nasal
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2021-01-07

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
Citelli rongeur In distribution
Ferris-Smith laminectomy kerrison rongeur In distribution
Blumenthal rongeur In distribution
Goldman-Kazanjian rongeur In distribution
Kerrison rongeur In distribution
Kerrison-Costen rongeur In distribution
Ferris-Smith laminectomy kerrison rongeur In distribution
Ruskin-Liston rongeur In distribution
Kerrison rongeur In distribution
Ruskin-Liston rongeur In distribution
Citelli rongeur In distribution
Kerrison rongeur In distribution
Citelli rongeur In distribution
Kazanjian rongeur In distribution
Bone cutting rongeur In distribution
Kerrison rongeur In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tri-D Kerrison Rongeur Mizuho Corporation 20
Jedmed Jedmed Instrument Company 17
Integra® Miltex® Integra LifeSciences Production Corporation 17
Integra® Jarit® Integra LifeSciences Production Corporation 13
Rongeur, Nasal Biomet Microfixation 11
Integra® Integra LifeSciences Production Corporation 11
Kerrison rongeur Mizuho Corporation 10
Millennium Avalign Technologies, Inc. 9
Marina Medical Marina Medical Instruments, Inc. 9
Avalign Avalign Technologies, Inc. 9
Rongeur KLS-Martin L.P. 9
Inka The Trustee for Kaiser Family Trust 8

Showing 12 of 33. All products under Rongeur, Nasal

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