FDA.report

Bioseal Inc.

Primary DI
10630094713318
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17133/30
Device description
Cable Ties
Published
2023-09-18
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
KDDKit, surgical instrument, disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094713318PackageGS130In Commercial Distribution
00630094713311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009471331810630094713318
00630094713311006300947133116300947133110630094713311

GMDN Terms

TermDefinition
Medical/surgical interventional tube/cable securement strapA strip of material in the form of tape/strap intended to be used to secure interventional patient tubes/cables to drapes or device covers in surgical/medical settings; it is not intended to attach to the patient and has no additional intended uses. It may be comprised of, e.g., an adhesive on one side to allow attachment to a drape/cover and Velcro on the other side for securing tubing/cables. 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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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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