FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
00630094171470
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17147/01
Device description
Go-Pro Head Mount
Published
2023-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ILZACCESSORIES, TRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILZAccessories, TractionPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094171477PackageGS11In Commercial Distribution
00630094171470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009417147710630094171477
00630094171470006300941714706300941714700630094171470

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA non-powered device designed to hold or stabilize a video camera or endoscope (e.g., to a table or rail) while recording a surgical operative procedure. This is a reusable device.

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630094198514Bioseal Inc.19851NS/1002023-12-07
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
00630094489025Bioseal Inc.DURA902/1002025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888912296533CHATTANOOGADJO, LLCILZ2024-08-20
10630094171477Bioseal Inc.BIOSEALILZ2023-09-18
00630094163604Bioseal Inc.BIOSEALILZ2023-09-13
00630094163635Bioseal Inc.BIOSEALILZ2023-09-13
00630094163642Bioseal Inc.BIOSEALILZ2023-09-13
00630094163659Bioseal Inc.BIOSEALILZ2023-09-13
00630094163666Bioseal Inc.BIOSEALILZ2023-09-13
00630094163727Bioseal Inc.BIOSEALILZ2023-09-13
10630094163601Bioseal Inc.BIOSEALILZ2023-09-13
10630094163632Bioseal Inc.BIOSEALILZ2023-09-13
10630094163649Bioseal Inc.BIOSEALILZ2023-09-13
10630094163656Bioseal Inc.BIOSEALILZ2023-09-13
10630094163663Bioseal Inc.BIOSEALILZ2023-09-13
10630094163724Bioseal Inc.BIOSEALILZ2023-09-13
04260676050082RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04260676050099RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04719871180372EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180389EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180396EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180402EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
00888912268806CHATTANOOGADJO, LLCILZ2023-04-18
00888912268851CHATTANOOGADJO, LLCILZ2023-04-18
00888912258746CHATTANOOGADJO, LLCILZ2022-12-01
00749756022088DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022101DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022118DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022132DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022255DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756097253DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756097291DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29