FDA.report

Bioseal Inc.

Primary DI
10630094199891
Brand
Bioseal Inc.
Company
BIOSEAL
Model
19989/25
Device description
Button 1/2"
Published
2023-12-19
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
KGSRETENTION DEVICE, SUTURE

Product Code Classifications

CodeDeviceSpecialtyClass
KGSRetention Device, SutureGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094199891PackageGS125In Commercial Distribution
00630094199894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009419989110630094199891
00630094199894006300941998946300941998940630094199894

GMDN Terms

TermDefinition
Suture retention deviceA device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. 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
10860011629419V-CloseDRS Vascular, Inc.KGS2026-03-09
00810178880652ViveVIVE HEALTH LLCKGS2026-02-05
00810178880669ViveVIVE HEALTH LLCKGS2026-02-05
10850012846687SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
00851424007157LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
20888277381763MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
00884450786192Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
10860011629402Q-StopDRS Vascular, Inc.KGS2024-05-23
10630094199815Bioseal Inc.BIOSEALKGS2023-12-19
10630094199839Bioseal Inc.BIOSEALKGS2023-12-19
10630094199860Bioseal Inc.BIOSEALKGS2023-12-19
10630094199877Bioseal Inc.BIOSEALKGS2023-12-19
10630094199716Bioseal Inc.BIOSEALKGS2023-12-12
10630094199730Bioseal Inc.BIOSEALKGS2023-12-12
10630094199754Bioseal Inc.BIOSEALKGS2023-12-12
10630094199785Bioseal Inc.BIOSEALKGS2023-12-12
10630094199808Bioseal Inc.BIOSEALKGS2023-12-12
10630094997251Bioseal Inc.BIOSEALKGS2023-12-12
10630094997329Bioseal Inc.BIOSEALKGS2023-12-12
10630094997428Bioseal Inc.BIOSEALKGS2023-12-12
10630094997626Bioseal Inc.BIOSEALKGS2023-12-12
10630094199310Bioseal Inc.BIOSEALKGS2023-12-11
10630094194490Bioseal Inc.BIOSEALKGS2023-10-11
10630094194681Bioseal Inc.BIOSEALKGS2023-10-11
10630094192342Bioseal Inc.BIOSEALKGS2023-10-09
10630094192397Bioseal Inc.BIOSEALKGS2023-10-09
10630094192410Bioseal Inc.BIOSEALKGS2023-10-09
20888277383149MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KGS2023-10-09
00850291007420FlowStasis Single-PackINARI MEDICAL INCKGS2023-07-19
34063107100452Stent ButtonsBoston Medical Products, Inc.KGS2022-09-29