FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094013227
Brand
Bioseal Inc.
Company
BIOSEAL
Model
1322/25
Device description
Stockinette Tubular 2"x72" 2ply
Published
2020-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094013227PackageGS125In Commercial Distribution
00630094013220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009401322710630094013227
00630094013220006300940132206300940132200630094013220

GMDN Terms#

Term, Definition table
TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast or splint; or to cover a stump when a prosthesis is worn. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00630094198514Bioseal Inc.19851NS/1002023-12-07
00630094171470Bioseal Inc.17147/012023-09-18
00630094017501Bioseal Inc.1750/502023-09-25
10630094481026Bioseal Inc.DURA102/1002025-05-29
10630094481231Bioseal Inc.DURA123/1002025-05-29
10630094483006Bioseal Inc.DURA300/1002025-05-29
10630094485055Bioseal Inc.DURA505/1002025-05-29
10630094485123Bioseal Inc.DURA512/1002025-05-29
10630094487028Bioseal Inc.DURA702/1002025-05-29
10630094487059Bioseal Inc.DURA705/1002025-05-29
10630094487301Bioseal Inc.DURA730/1002025-05-29
10630094489022Bioseal Inc.DURA902/1002025-05-29
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426264605Medline-MicrotekMicrotek Medical LLCPUI2026-10-13
00748426264636Medline-MicrotekMicrotek Medical LLCPUI2026-10-13
07467423230682Smith and NephewDAS Medical International SRLPUI2026-10-13
00748426264568Medline-MicrotekMicrotek Medical LLCPUI2026-10-12
16931918199627AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-09-29
10809160538999HalyardMEDICAL ACTION INDUSTRIES INC.PUI2026-09-24
10850091824002AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10850091824019AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10197344220083MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
10197344220090MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
16942748475843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-09-08
00197998192814Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998304996Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
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00197998305153Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
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00197998312397Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312434Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312458Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312472Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312496Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329678Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329708Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329739Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329760Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23