Titan SGS Bailout Chuck SBC

GUDID 10851677007109

Titan SGS Bailout Chuck

STANDARD BARIATRICS, INC

Endoscopic motorized cutting stapler, single-use
Primary Device ID10851677007109
NIH Device Record Key8d2bf6eb-9e64-4203-b38f-eea9932bd337
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitan SGS Bailout Chuck
Version Model NumberSBC
Catalog NumberSBC
Company DUNS091278068
Company NameSTANDARD BARIATRICS, INC
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 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
GS100851677007102 [Primary]
GS110851677007109 [Package]
Contains: 00851677007102
Package: Inner Pack [5 Units]
In Commercial Distribution
GS120851677007106 [Package]
Package: Case [5 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 Date2024-07-22
Device Publish Date2024-07-12

Devices Manufactured by STANDARD BARIATRICS, INC

10851677007109 - Titan SGS Bailout Chuck2024-07-22Titan SGS Bailout Chuck
10851677007109 - Titan SGS Bailout Chuck2024-07-22 Titan SGS Bailout Chuck
00851677007140 - Atlas SSLR Buttress Assembly2024-07-18 Atlas SSLR Buttress Assembly
00851677007171 - Standard Precision Bougie Device2024-07-11 Standard Precision Bougie Device Non-Sterile 38Fr
00851677007164 - Titan SGS Standard Gastric Stapler2023-10-31
10851677007123 - Standard Tapered Bougie, 38Fr2022-12-06
00851677007133 - Titan SGS Standard Gastric Stapler2022-06-10
10851677007116 - Standard Bougie Handpump2021-12-30
00851677007072 - Standard Bougie, 38Fr2021-08-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.