FDA.report

Bioseal Inc.

Primary DI
10630094130511
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17130NS/25
Device description
Bone Flap Sticker
Published
2023-09-20
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

Related Records

Product Codes

CodeName
LYVLABEL OR TAG, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094130511PackageGS125In Commercial Distribution
00630094130514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009413051110630094130511
00630094130514006300941305146300941305140630094130514

GMDN Terms

TermDefinition
Printer label IVDA thin, blank sheet of fibrous material, typically with an adhesive underside, intended to be imprinted with an image/text using a printer, and then applied to an object for identification (e.g., barcode) or information associated with an in vitro diagnostic procedure. It is typically available as a continuous roll with individual labels arranged on a waxy backing sheet for easy peeling. This is a single-use device.

Sterilization Methods

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 DIBrandModelCatalogPublished
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
00630094480503Bioseal Inc.DURA050/1002025-05-28
10630094292240Bioseal Inc.32-922-4/202024-01-10
10630094335404Bioseal Inc.33-540/202024-01-10
10630094055111Bioseal Inc.551S/202024-01-29
10630094055135Bioseal Inc.551L/202024-01-29
10630094055142Bioseal Inc.551M/202024-01-29
10630094055197Bioseal Inc.551R/202024-01-29
10630094061501Bioseal Inc.6150/252024-01-29
10630094061518Bioseal Inc.6151/252024-01-29
10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B050SL1000021Sterile LabelsTYPENEX MEDICAL LLCLYV2026-03-17
17540277009646PharmaTagsRMAC Surgical, IncLYV2026-03-12
17540277009639PharmaTagsRMAC Surgical, IncLYV2026-03-03
17540277000001PharmaTagsRMAC Surgical, IncLYV2026-02-06
10754027700104PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700111PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700142PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700173PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700265PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700715PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700722PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700739PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700746PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700753PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700777PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700784PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700791PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700807PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700814PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700821PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700838PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700845PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700852PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700869PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700876PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700883PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700890PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700906PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700913PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700920PharmaTagsRMAC Surgical, IncLYV2026-02-02