FDA.reportPublic FDA data

Atlas SSLR Buttress Assembly

Primary DI
00851677007140
Brand
Atlas SSLR Buttress Assembly
Company
STANDARD BARIATRICS, INC
Model
IPN928199
Catalog number
SSLR23
Device description
Atlas SSLR Buttress Assembly
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OXCMesh, Surgical, Absorbable, Staple Line Reinforcement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXCMesh, Surgical, Absorbable, Staple Line ReinforcementGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231603000Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.2023-10-06OXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20851677007144PackageGS16In Commercial Distribution
00851677007140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085167700714420851677007144
00851677007140008516770071408516770071400851677007140

GMDN Terms#

Term, Definition table
TermDefinition
Staple line-reinforcement stripA sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
091278068
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851677007102Titan SGS Bailout ChuckSBCSBC2024-07-12
10851677007109Titan SGS Bailout ChuckSBCSBC2024-07-12
00851677007171Standard Precision Bougie DeviceSTB38STB382024-07-03
00851677007157Titan SGS Standard Gastric StaplerSGS23R2023-10-23
00851677007164Titan SGS Standard Gastric StaplerSGS23R2023-10-23
00851677007126Standard Tapered Bougie, 38FrSTB382022-11-28
10851677007123Standard Tapered Bougie, 38FrSTB382022-11-28
00851677007058Standard BougieSB18-12020-04-27
00851677007065Standard Bougie, 38FrSB382021-08-18
00851677007119Standard Bougie HandpumpSBHP2021-12-22
00851677007133Titan SGS Standard Gastric StaplerSGS23Rb2022-06-02
10851677007116Standard Bougie HandpumpSBHP2021-12-22
00851677007072Standard Bougie, 38FrSB382021-08-18
00851677007089Titan SGS Standard Gastric StaplerSGS23R2021-08-18
00851677007096TITAN Standard Power UnitSPU012021-08-18
00851677007041Standard TrocarST19-1ST192020-04-27
10851677007048Standard TrocarST19-12020-04-27
10851677007055Standard BougieSB18-12020-04-27
00851677007027Standard Clamp, DisposableSCD22-12020-01-23
00851677007003Standard Clamp, Disposable SCD25-1SCD25-12017-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548366322450NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322467NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322474NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322498NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322504NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322511NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322528NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322535NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322542NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322559NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830313NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830337NEOVEILGUNZE LIMITEDOXC2025-04-21
04973077713776NEOVEILGUNZE LIMITEDOXC2023-03-27
04973077713783NEOVEILGUNZE LIMITEDOXC2023-03-27
10705036023296ECHLEONETHICON ENDO-SURGERY, LLCOXC2021-11-17
20705036023293ECHLEONETHICON ENDO-SURGERY, LLCOXC2021-11-17
04547301462534NEOVEILGUNZE LIMITEDOXC2021-01-06
04547301462558NEOVEILGUNZE LIMITEDOXC2021-01-06
04548366322481NEOVEILGUNZE LIMITEDOXC2019-11-04
00733132644568GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644575GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644582GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644599GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644605GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644612GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644629GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644636GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644643GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644650GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644667GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28