FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
00630094188300
Brand
Bioseal Inc.
Company
BIOSEAL
Model
18830/20
Device description
Sand Paper 180 Grit
Published
2023-10-05
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
GEDBRUSH, DERMABRASION, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEDBrush, Dermabrasion, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094188307PackageGS120In Commercial Distribution
00630094188300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009418830710630094188307
00630094188300006300941883006300941883000630094188300

GMDN Terms#

Term, Definition table
TermDefinition
Nail emery boardA hand-held manual device intended to grind down fingernails or toenails with an abrasive action typically to remove debris and/or smooth the nail. It is in the form of a double-sided wooden file with an emery paper covering. It is available for use by a patient/layperson outside a clinical environment. 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
10197344029686MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
30197344029680MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
00630094188256Bioseal Inc.BIOSEALGED2023-10-05
00630094188263Bioseal Inc.BIOSEALGED2023-10-05
00630094188409Bioseal Inc.BIOSEALGED2023-10-05
00630094188706Bioseal Inc.BIOSEALGED2023-10-05
00630094188904Bioseal Inc.BIOSEALGED2023-10-05
00630094188911Bioseal Inc.BIOSEALGED2023-10-05
00630094188928Bioseal Inc.BIOSEALGED2023-10-05
00630094188935Bioseal Inc.BIOSEALGED2023-10-05
10630094188253Bioseal Inc.BIOSEALGED2023-10-05
10630094188260Bioseal Inc.BIOSEALGED2023-10-05
10630094188307Bioseal Inc.BIOSEALGED2023-10-05
10630094188406Bioseal Inc.BIOSEALGED2023-10-05
10630094188703Bioseal Inc.BIOSEALGED2023-10-05
10630094188901Bioseal Inc.BIOSEALGED2023-10-05
10630094188918Bioseal Inc.BIOSEALGED2023-10-05
10630094188925Bioseal Inc.BIOSEALGED2023-10-05
10630094188932Bioseal Inc.BIOSEALGED2023-10-05
00850019947847Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947878Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947632Dermal Cooling SystemR2 DERMATOLOGY INC.GED2023-06-09
B7687834600Buxton BioMedicalBuxton Biomedical IncGED2023-01-10
00827002485273CookCOOK INCORPORATEDGED2020-10-02
00860371002306Norsen Debrider, SterileBEL-MED, INC.GED2019-05-29