Boss Instruments

VATS Harken #2 Clamp - 10mm Shaft 95mm Debakey 1x2 Jaws, Fully Curved Left 9-4/5" WL, 14" OL, Without Ratchet

Registry build 21.09.26
10manufacturers in China registered for this device type
457catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXC
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Shanghai INT Medical Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Tianjin Demax Medical Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 5
Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Joykey Industrial (Pinghu) Limited Pinghu Zhejiang Contract manufacturer 43
Sunny Medical Device (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Lepu Medical Technology (Beijing) Co., Ltd. Beijing Beijing Manufacturer 7
Terumo Medical Products (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Beijing Target Medical Technologies Inc. Beijing Beijing Contract manufacturer 7
Beijing Demax Medical Technology Co., Ltd. Beijing Beijing Manufacturer 5

Record

Regulatory record for Boss Instruments
Listed by Boss Instruments, Ltd., United States
FDA product code DXC
Device type Clamp, Vascular
Device class Class 2
Regulation 21 CFR 870.4450
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2018-09-21
Record revised 2024-02-19 (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 2023-12-31

Catalogue Numbers

Catalogue numbers for Boss Instruments
Catalogue number Size Status
65-6863 In distribution
65-6966A In distribution
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Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 831
Novo Surgical Novo Surgical, Inc. 708
Ambler Surgical Ambler Surgical, LLC 575
Pilling Teleflex Medical LLC 544
Avalign Avalign Technologies, Inc. 543
V. Mueller Steris Corporation 432
Wexler Surgical, Inc. Wexler Surgical, Inc. 342
Integra® Jarit® Integra LifeSciences Production Corporation 331
Scanlan® Scanlan International, Inc. 294
HNM Medical HNM Stainless, LLC. 230
Aesculap Aesculap AG 136
Pilling Avalign Technologies, Inc. 128

Showing 12 of 639. All products under Clamp, Vascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K980002 1998-06-18

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