Atlas SSLR Buttress Assembly SSLR23

GUDID 00851677007140

Atlas SSLR Buttress Assembly

STANDARD BARIATRICS, INC

Staple line-reinforcement strip
Primary Device ID00851677007140
NIH Device Record Key9d18211b-92aa-4b1d-81e7-a4af5bbf1493
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtlas SSLR Buttress Assembly
Version Model NumberIPN928199
Catalog NumberSSLR23
Company DUNS091278068
Company NameSTANDARD BARIATRICS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100851677007140 [Primary]
GS120851677007144 [Package]
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXCMesh, Surgical, Absorbable, Staple Line Reinforcement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-18
Device Publish Date2024-07-10

Devices Manufactured by STANDARD BARIATRICS, INC

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00851677007140 - Atlas SSLR Buttress Assembly2024-07-18Atlas SSLR Buttress Assembly
00851677007140 - Atlas SSLR Buttress Assembly2024-07-18 Atlas SSLR Buttress Assembly
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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

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