FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094177929
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17792/50
Device description
Breast Pad
Published
2023-10-05
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
FMPProtector, skin pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094177929PackageGS150In Commercial Distribution
00630094177922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009417792910630094177929
00630094177922006300941779226300941779220630094177922

GMDN Terms#

Term, Definition table
TermDefinition
Nipple pad/ring, single-useA device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. 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
00089904011428Action®ACTION PRODUCTS, INC.FMP2026-07-17
00089904011411Action®ACTION PRODUCTS, INC.FMP2026-07-06
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00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
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00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
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00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166028DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166035DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166066DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166073DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166080DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166097DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08