Snowden-Pencer

Snowden-Pencer SLIDELOCK ATRAUMATIC GRASPER SINGLE-PIECE, SINGLE ACTION 45CM, 5MM, 22MM JAW INSUL SHAFT, NON-ROT, RATCHETED

Registry build 21.09.26
7manufacturers in China registered for this device type
22catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HET
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19
Global Medical Production Co., Ltd. Jiaxing Zhejiang Manufacturer 10
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Cixi Zhejiang Manufacturer 8
Guangdong Optomedic Technologies, Inc. Foshan Guangdong Manufacturer 7

Record

Regulatory record for Snowden-Pencer
Listed by Steris Corporation, United States
FDA product code HET
Device type Laparoscope, Gynecologic (And Accessories)
Device class Class 2
Regulation 21 CFR 884.1720
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2018-02-23
Record revised 2024-08-12 (version 8)

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Snowden-Pencer
Catalogue number Size Status
88-8546 In distribution
88-8533 In distribution
88-8245 In distribution
88-8433 In distribution
88-9809 In distribution
88-8313 In distribution
88-5920 In distribution
88-8423 In distribution
88-9808 In distribution
88-8333 In distribution
88-8308 In distribution
88-8446 In distribution
88-5910 In distribution
88-8345 In distribution
88-8314 In distribution
88-8246 In distribution
88-8323 In distribution
88-8346 In distribution
88-8302 In distribution
88-8523 In distribution
88-8233 In distribution
88-8307 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Endoplus Endoplus 448
Integra® MicroFrance® Integra Microfrance SAS 273
Symmetry Surgical® Aspen Surgical Products, Inc. 139
Laparoscope, Gynecologic (And Accessories) Karl Storz GmbH & Co. KG 119
Elmed Elmed, Inc. 96
Olympus Olympus Winter & IBE Gmbh 71
Core Dynamics ConMed Corporation 52
Symmetry Aspen Surgical Products, Inc. 48
DANmed Dannoritzer Medizintechnik GmbH & Co. KG 45
Laparoscope, Gynecologic (And Accessories) Richard Wolf Gmbh 37
Take-Apart Karl Storz GmbH & Co. KG 31
Blueendo Trokamed Gmbh 28

Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Snowden-Pencer
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Carefusion 2200, Inc. UDI-DI 2022-02-23 Class II Nonconforming Material/Component The finished device package did not contain the IFU. 152 units 2023-05-02

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