FDA.report

Bioseal Inc.

Primary DI
10630094174362
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17436/20
Device description
Nylon Dressing Olive
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
GDYGauze/sponge, internal, x-ray detectable

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094174362PackageGS120In Commercial Distribution
00630094174365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009417436210630094174362
00630094174365006300941743656300941743650630094174365

GMDN Terms

TermDefinition
Skin treatment/dressing-supportive limb/finger bandage, single-useAn elastic, tubular device intended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury; it is not designed for tissue support/compression. It is typically made of non-allergenic natural materials or a composite (e.g., viscose/nylon/elastane), and intended for use in the home and 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

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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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