FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094303458
Brand
Bioseal Inc.
Company
BIOSEAL
Model
3034W/24
Device description
Cast Padding Bi-Web
Published
2023-12-29
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
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094303458PackageGS124In Commercial Distribution
00630094303451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009430345810630094303458
00630094303451006300943034516300943034510630094303451

GMDN Terms#

Term, Definition table
TermDefinition
Cast stockinetteA knitted, seamless tube of material, typically cotton, designed to stretch and fit any contour of the body. It is typically used as padding under a cast or splint. 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
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
16931918102054HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918103969HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
10197106935132CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
10810178830135Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830142Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830159Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830166Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10653160382928MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15
10193489009460REMEDYMEDLINE INDUSTRIES, INC.FRL2024-10-24
10193489012521MEDLINEMEDLINE INDUSTRIES, INC.FRL2024-10-24
10850049784402SURGYCOSurgyco LLCFRL2023-12-15
10850049784419SURGYCOSurgyco LLCFRL2023-12-15
10810132041843HCSConcordance Healthcare Solutions LLCFRL2023-10-16
10884389108949MedlineMEDLINE INDUSTRIES, INC.FRL2023-10-12
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10850054813302Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813319Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813098Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12
10850054813104Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12