Who else makes this device?

Name: Dura Separator, Standard, Reusable
Brand: Dura Separator, Standard, Reusable

Neurology › SurgicalInstrument, Surgical, Non-Powered

Dura Separator, Standard, Reusable

Dura Separator, Standard, Reusable Set Consisting Of One Each #0 Cat#800-710 ID#00810607000521,#1 Cat#800-711 ID#00810607000538,#2 Cat#800-712 ID#0081060700545,#3 Cat#800-713…

Registry build 21.09.26

Dura Separator, Standard, Reusable Set Consisting Of One Each #0 Cat#800-710 ID#00810607000521,#1 Cat#800-711 ID#00810607000538,#2 Cat#800-712 ID#0081060700545,#3 Cat#800-713 ID#0081060700552

4manufacturers in China registered for this device type

5catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Beijing (1).

Chinese manufacturers registered for FDA product code HAO
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
Shanghai Wilpower Industrial Co., Ltd.	Shanghai	Shanghai	Exporter	33
Hotry Co., Ltd.	Beijing	Beijing	Manufacturer	9

Record

Regulatory record for Dura Separator, Standard, Reusable
Listed by	Acra CUT, Inc., United States
FDA product code	HAO
Device type	Instrument, Surgical, Non-Powered
Device class	Class 1
Regulation	21 CFR 882.4535
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2017-08-01
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Dura Separator, Standard, Reusable
Catalogue number	Size	Status
800-712		In distribution
800-713		In distribution
800-714		In distribution
800-711		In distribution
800-710		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Integra® Ruggles®-Redmond™	Integra LifeSciences Production Corporation	705
Ambler Surgical	Ambler Surgical, LLC	597
V. Mueller	Steris Corporation	577
Millennium	Avalign Technologies, Inc.	383
Avalign	Avalign Technologies, Inc.	352
Novo Surgical	Novo Surgical, Inc.	300
Novo Surgical Inc.	Novo Surgical, Inc.	283
Boss Instruments	Boss Instruments, Ltd.	263
Pilling	Teleflex Medical LLC	156
Instrument, Surgical, Non-Powered	Karl Storz GmbH & Co. KG	130
Instrument, Surgical, Non-Powered	Fehling Instruments GmbH	126
Integra® Jarit®	Integra LifeSciences Production Corporation	109

Showing 12 of 249. All products under Instrument, Surgical, Non-Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K910225	1991-02-12
K910226	1991-02-12

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.