Noir

KERRISON NOIR Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), regular, width: 3 mm, opening width: 10 mm, detachable, with ejector, standard, non-sterile, reusable, to be…

Registry build 21.09.26

KERRISON NOIR Bone Punch conventional, 130 °, upwards cutting, 7 7/8″, (200 mm), regular, width: 3 mm, opening width: 10 mm, detachable, with ejector, standard, non-sterile, reusable, to be used with: JF120R

9manufacturers in China registered for this device type
66catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code LRY
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
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
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24

Record

Regulatory record for Noir
Listed by Aesculap AG, Germany
FDA product code LRY
Device type Punch, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-06-17
Record revised 2023-04-20 (version 5)

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
Distribution end date 2022-07-08

Catalogue Numbers

Catalogue numbers for Noir
Catalogue number Size Status
FK949B In distribution
FK986B In distribution
FB194B In distribution
FK903B In distribution
FK983B In distribution
FK963B In distribution
FK976B In distribution
FK914B In distribution
FK968B In distribution
FK918B In distribution
FK922B In distribution
FK948B In distribution
FK906B In distribution
FK928B In distribution
FK950B In distribution
FK926B In distribution
FK970B In distribution
FK952B In distribution
FK971B In distribution
FK913B In distribution
FK904B In distribution
FK974B In distribution
FK982B In distribution
FK923B In distribution
FK981B In distribution
FK961B In distribution
FK964B In distribution
FK905B In distribution
FK966B In distribution
FK979B In distribution
FK901B In distribution
FK919B In distribution
FK929B In distribution
FK960B In distribution
FK920B In distribution
FK984B In distribution
FK909B In distribution
FK973B In distribution
FK907B In distribution
FK962B In distribution
FK902B In distribution
FK912B In distribution
FK900B In distribution
FK978B In distribution
FK924B In distribution
FK951B In distribution
FK972B In distribution
FK916B In distribution
FK908B In distribution
FK921B In distribution
FK911B In distribution
FK988B In distribution
FK967B In distribution
FK965B In distribution
FK969B In distribution
FK987B In distribution
FK989B In distribution
FK927B In distribution
FK915B In distribution
FK925B In distribution
FK917B In distribution
FK910B In distribution
FK977B In distribution
FK953B Withdrawn
FK975B Withdrawn
FK980B Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 693
Ambler Surgical Ambler Surgical, LLC 317
Orthomed Ortho-MED, Inc. 228
Aesculap Aesculap AG 187
Lazic Peter Lazic Gmbh 148
MaxMoreSpine Hoogland Spine Products GmbH 44
Kerrison Elliquence LLC 36
Integra® Miltex® Integra LifeSciences Production Corporation 33
Punch, Surgical Doppkon Gmbh & Co. KG 29
Scharf Scharf Tools Ihracat Ithalat Limited Sirketi 29
Henry Schein Henry Schein, Inc. 27
ACE Ace Surgical Supply Co., Inc. 25

Showing 12 of 216. All products under Punch, Surgical

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