Scanlan® Sternum Scissors

SCANLAN® Sternum Scissors, serrated blades, curved sideways, 8" / 20 cm

Registry build 21.09.26
6manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

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 Scanlan® Sternum Scissors
Listed by Scanlan International, 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
Premarket notification Exempt
Record published 2020-01-24
Record revised 2022-09-23 (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

Catalogue Numbers

Catalogue numbers for Scanlan® Sternum Scissors
Catalogue number Size Status
Q28037-7 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K851825 1985-07-12
K823764 1983-03-24

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