FDA.reportPublic FDA data

Benchmark Sterilization Pouch

Primary DI
00850091155123
Brand
Benchmark Sterilization Pouch
Company
BENCHMARK MEDICAL INSTRUMENTS INC.
Model
B4031-0510
Device description
Benchmark Sterilization Pouch, 5.25 x 10 Self Sealing, 200/pk.
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850091155222PackageGS11In Commercial Distribution
00850091155123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091155222008500911552228500911552220850091155222
00850091155123008500911551238500911551230850091155123

Regulatory Flags#

DUNS number
143773373
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850091155000Benchmark BM-3B4030-BM32026-10-30
00850091155017Benchmark BM-7B4030-BM72026-10-30
00850091155024Benchmark BM-10B4030-BM102026-10-30
00850091155031Benchmark BM-11B4030-BM112026-10-30
00850091155048Benchmark BM-12XLB4030-BM12XL2026-10-30
00850091155109Benchmark Sterilization PouchB4031-03052026-10-30
00850091155116Benchmark Sterilization PouchB4031-03102026-10-30
00850091155130Benchmark Sterilization RollB4032-752026-10-30
00850091155147Benchmark Sterilization RollB4032-1502026-10-30
00850091155154Benchmark Sterilization RollB4032-2002026-10-30
00850091155161Benchmark Sterilzation WrapB4033-122026-10-30
00850091155178Benchmark Sterilzation WrapB4033-152026-10-30
00850091155185Benchmark Sterilzation WrapB4033-242026-10-30
00850091155192Benchmark Sterilzation WrapB4033-362026-10-30
00850091155307Benchmark BM-8B4030-BM82026-10-30
00850091155314Benchmark BM-10XLB4030-BM10XL2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155161Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155178Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155185Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155192Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
08404535038446Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-30
08404535037654Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
08404535037685Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
00724995239985V. MuellerSteris CorporationFRG2026-10-15
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20884389188269GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188256GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190426GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190453GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115498GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188270GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190440GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389188283GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190484GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09