Ambler Surgical

Microsurgical clamp applying forceps, 5 1/2'', angled, for clamps size B-1, B-2 & B-3 (0.4mm - 2.25mm), flat handle, without lock

Registry build 21.09.26
9manufacturers in China registered for this device type
19catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GDO
Manufacturer City Province Registered as Device types
Sunny Medical Device (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Jiangsu Bana Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 4
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24
Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
Tianjin Huahong Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 6
Sinolinks Medical Innovation, Inc. Changzhou Jiangsu Complaint-file establishment 5
Fengh Medical Co., Ltd. Jiangyin Jiangsu Manufacturer 4

Record

Regulatory record for Ambler Surgical
Listed by Ambler Surgical, LLC, United States
FDA product code GDO
Device type Applier, Surgical, Clip
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2021-01-04
Record revised 2021-02-05 (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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Ambler Surgical
Catalogue number Size Status
Scoville clip applying forceps In distribution
Raney scalp clip In distribution
Raney clip applying forceps In distribution
Schwartz micro bulldog aneurysm clamp holding forceps In distribution
McKenzie clip applying forceps In distribution
LeRoy scalp clip applying forceps In distribution
Biemer vessel clip In distribution
Biemer vessel clip In distribution
Smithwick clip applying forceps In distribution
McKenzie clip applying forceps In distribution
McKenzie clip applying forceps In distribution
LeRoy scalp clip applying forceps In distribution
Biemer vessel clip In distribution
Scoville clip applying forceps In distribution
McKenzie clip applying forceps In distribution
Smithwick clip applying forceps In distribution
Sweet clip applying forceps In distribution
Microsurgical clamp applying forceps In distribution
Sweet clip applying forceps In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Weck Teleflex Medical LLC 996
Teleflex Teleflex Medical LLC 61
Aesculap Aesculap AG 46
Ligaclip Ethicon Endo-Surgery, Inc. 29
Surgical Direct Surgical Direct, Inc. 28
Elmed Elmed, Inc. 23
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 19
Europclip Ackermann Instrumente Gmbh 17
Lazic Peter Lazic Gmbh 15
Artisential Clip Applier Large LivsMed Inc. 14
Artisential Clip Applier Medium Large LivsMed Inc. 14
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 11

Showing 12 of 73. All products under Applier, Surgical, Clip

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