Bioseal Inc.

Primary DI
16300940114029
Brand
Bioseal Inc.
Company
BIOSEAL
Model
1140BX/50
Device description
Stockinette Bias
Published
2023-07-10
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
IPMCOVER, LIMB

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16300940114029PackageGS11In Commercial Distribution
00630094114026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1630094011402916300940114029
00630094114026006300941140266300941140260630094114026

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
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00636257046487MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046494MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046500MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046517MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046524MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
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00636257046692MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046708MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046715MEDIMEDI MANUFACTURING, INC.IPM2025-10-03