FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094011889
Brand
Bioseal Inc.
Company
BIOSEAL
Model
1188/25
Device description
Bias Stockinette
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
10630094011889PackageGS125In Commercial Distribution
00630094011882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009401188910630094011889
00630094011882006300940118826300940118820630094011882

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
20809160489885Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-08-01
20809160489465Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-07-31
08717127934409Arion Easy-Slide Arion Holding B.V.IPM2025-02-03
08717127934416Arion MagnideArion Holding B.V.IPM2025-02-03
08717127934423Arion Sim-Slide Arion Holding B.V.IPM2025-02-03
08717127934430Arion Easy-OffArion Holding B.V.IPM2025-02-03
08717127934447Arion Easy-Slide ArmArion Holding B.V.IPM2025-02-03
08717127934454Arion Proth-ProArion Holding B.V.IPM2025-02-03
08717127930111Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930401Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930432Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930463Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930494Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930555Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930586Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930616Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930647Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930678Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930708Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930739Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930760Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930791Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930821Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930852Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930883Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930913Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930944Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930975Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931002Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931040Arion SlideXArion Holding B.V.IPM2025-01-13