Titan SGS Standard Gastric Stapler

GUDID 00851677007164

STANDARD BARIATRICS, INC

Endoscopic manual linear cutting stapler, single-use
Primary Device ID00851677007164
NIH Device Record Key2a827f73-a17a-4940-8d16-dd07204b4307
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitan SGS Standard Gastric Stapler
Version Model NumberSGS23R
Company DUNS091278068
Company NameSTANDARD BARIATRICS, INC
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851677007157 [Primary]
GS100851677007164 [Package]
Contains: 00851677007157
Package: [3 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 Date2023-10-31
Device Publish Date2023-10-23

On-Brand Devices [Titan SGS Standard Gastric Stapler]

00851677007089SGS23R
00851677007133SGS23Rb
00851677007164SGS23R

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