Disposable Curved Cutter Staplers

GUDID 06946480510537

Sinolinks Medical Innovation Co., Ltd.

Open-surgery manual linear cutting stapler, single-use
Primary Device ID06946480510537
NIH Device Record Key9985f476-9e54-42b6-aff5-adeb988ee7a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Curved Cutter Staplers
Version Model NumberDCC B-40G
Company DUNS528192598
Company NameSinolinks Medical Innovation Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106946480510537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GDWStaple, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-12
Device Publish Date2025-09-04

Devices Manufactured by Sinolinks Medical Innovation Co., Ltd.

06946480501276 - Disposable Circular Staplers2025-09-12
06946480503638 - Disposable Linear Staplers and Reloads 2025-09-12
06946480510537 - Disposable Curved Cutter Staplers 2025-09-12
06946480510537 - Disposable Curved Cutter Staplers 2025-09-12
06946480563632 - Disposable Linear Staplers and Reloads2025-09-12
06946480576052 - Disposable Linear Cutter Staplers and Reloads 2025-09-12
06946480576151 - Disposable Linear Cutter Staplers and Reloads 2025-09-12
06946480584064 - Disposable Skin Staplers 2025-09-12
06946480584163 - Disposable Skin Staplers 2025-09-12

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