Single Use Circular Stapler

GUDID 16946912217017

Golden Stapler Surgical Co.,Ltd

Intraluminal circular stapler, single-use
Primary Device ID16946912217017
NIH Device Record Key422b4958-88ea-4093-bc59-cd44a0f6039c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Circular Stapler
Version Model NumberCSC21
Company DUNS527606074
Company NameGolden Stapler Surgical Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106946912217010 [Primary]
GS116946912217017 [Package]
Contains: 06946912217010
Package: [6 Units]
In Commercial Distribution

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 Date2019-06-24
Device Publish Date2019-06-14

On-Brand Devices [Single Use Circular Stapler]

16946912216034CSB26
16946912216027CSB23
16946912216010CSB21
16946912215068CSA34
16946912215051CSA32
16946912215044CSA29
16946912215037CSA26
16946912215020CSA23
16946912215013CSA21
16946912217062CSC34
16946912217055CSC32
16946912217048CSC29
16946912217031CSC26
16946912217024CSC23
16946912217017CSC21
16946912216065CSB34
16946912216058CSB32
16946912216041CSB29

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