FDA.report

Bioseal Inc.

Primary DI
10630094030644
Brand
Bioseal Inc.
Company
BIOSEAL
Model
3064/24
Device description
Cast Padding Bi-Web
Published
2023-12-29
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
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094030644PackageGS124In Commercial Distribution
00630094030647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009403064410630094030644
00630094030647006300940306476300940306470630094030647

GMDN Terms

TermDefinition
Cast stockinetteA knitted, seamless tube of material, typically cotton, designed to stretch and fit any contour of the body. It is typically used as padding under a cast or splint. 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

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10630094055111Bioseal Inc.551S/202024-01-29
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10630094061501Bioseal Inc.6150/252024-01-29
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10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

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