Aortic Punch

Aortic Punch APU448 - 4.8mm punch size

Registry build 21.09.26
6manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code DWS
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
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22
Huaian Wolfram Surgical Instruments Huaian Jiangsu Manufacturer 14
Global Medical Production Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Aortic Punch
Listed by Medtronic, Inc., United States
FDA product code DWS
Device type Instruments, Surgical, Cardiovascular
Device class Class 1
Regulation 21 CFR 870.4500
Establishment Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2025-03-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number
Storage Special storage condition: Keep Dry; Special storage condition: Keep away from sunlight
Packaging Pack of 6
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aortic Punch
Catalogue number Size Status
APU448 Punch Diameter: 4.8 mm In distribution
APU460 Punch Diameter: 6.0 mm In distribution
APU552 Punch Diameter: 5.2 mm In distribution
APU430 Punch Diameter: 3.0 mm In distribution
APU550 Punch Diameter: 5.0 mm In distribution
APU456 Punch Diameter: 5.6 mm In distribution
APU425 Punch Diameter: 2.5 mm In distribution
APU540 Punch Diameter: 4.0 mm In distribution
APU560 Punch Diameter: 6.0 mm In distribution
APU450 Punch Diameter: 5.0 mm In distribution
APU544 Punch Diameter: 4.4 mm In distribution
APU548 Punch Diameter: 4.8 mm In distribution
APU530 Punch Diameter: 3.0 mm In distribution
APU444 Punch Diameter: 4.4 mm In distribution
APU440 Punch Diameter: 4.0 mm In distribution
APU535 Punch Diameter: 3.5 mm In distribution
APU556 Punch Diameter: 5.6 mm In distribution
APU452 Punch Diameter: 5.2 mm In distribution
APU435 Punch Diameter: 3.5 mm In distribution
APU525 Punch Diameter: 2.5 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Delacroix-Chevalier Landanger 1,819
Landanger Landanger 1,213
Ambler Surgical Ambler Surgical, LLC 1,013
Pilling Teleflex Medical LLC 971
Wexler Surgical, Inc. Wexler Surgical, Inc. 876
V. Mueller Steris Corporation 716
Novo Surgical Novo Surgical, Inc. 387
Integra® Jarit® Integra LifeSciences Production Corporation 364
Instruments, Surgical, Cardiovascular Fehling Instruments GmbH 352
Novo Surgical Inc. Novo Surgical, Inc. 290
Avalign Avalign Technologies, Inc. 283
Millennium Avalign Technologies, Inc. 272

Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular

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