Shard

Disposable Stainless Steel Biopsy Punch Sterile. 1.5mm.

Registry build 21.09.26
1manufacturer
9catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code EME
Manufacturer City Province Registered as Device types
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Shard
Listed by Applied Dental, Inc.
FDA product code EME
Device type Punch, Biopsy, Surgical
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2022-03-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature up to 40 °C
Packaging Carton of 10

Catalogue Numbers

Catalogue numbers for Shard
Catalogue number Size Status
A750-BP15 In distribution
A750-BP40 In distribution
A750-BP20 In distribution
A750-BP50 In distribution
A750-BP35 In distribution
A750-BP30 In distribution
A750-BP80 In distribution
A750-BP25 In distribution
A750-BP60 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 36
Sklar Instruments Sklar Corporation 24
Kohdent Kohler Medizintechnik GmbH 22
Osung MND Osung MND Co., Ltd. 20
Medline Medline Industries, Inc. 20
Acu-Punch Acuderm, Inc. 17
Gynex Gynex Corporation 13
Exel Biopsy Punch Exel Inc. 11
Biotanium Basic Dental Implant Systems, Inc. 7
Punches, Nobel Omnia Medical 6
Salvin Stainless Steel Multi-Use Rotary Tissue Punch – 4mm Salvin Dental Specialties, LLC 5
Salvin Dental Specialties Salvin Dental Specialties, LLC 4

Showing 12 of 64. All products under Punch, Biopsy, 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