FDA.report

Bioseal Inc.

Primary DI
10630094047604
Brand
Bioseal Inc.
Company
BIOSEAL
Model
4760/25
Device description
Elastic Bandage Self-Closure
Published
2024-01-23
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
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094047604PackageGS125In Commercial Distribution
00630094047607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009404760410630094047604
00630094047607006300940476076300940476070630094047607

GMDN Terms

TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. 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

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