FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
00630094198033
Brand
Bioseal Inc.
Company
BIOSEAL
Model
19803/50
Device description
Alkaline Battery
Published
2023-12-07
Public version status
New
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094198030PackageGS150In Commercial Distribution
00630094198033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009419803010630094198030
00630094198033006300941980336300941980330630094198033

GMDN Terms#

Term, Definition table
TermDefinition
Disposable battery packA group of battery cells (e.g., lithium ion cells) held within a container that is sterile used to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. This device is typically designed to power cordless surgical power tools (e.g., a non-rechargeable battery-powered surgical drilling system handpiece) and is non-rechargeable. This is a single-use 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
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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