FDA.report

Bioseal Inc.

Primary DI
10630094042999
Brand
Bioseal Inc.
Company
BIOSEAL
Model
4299/24
Device description
Cigarette Drain
Published
2024-01-17
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
GAXTOURNIQUET, NONPNEUMATIC

Product Code Classifications

CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094042999PackageGS124In Commercial Distribution
00630094042947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009404299910630094042999
00630094042947006300940429476300940429470630094042947

GMDN Terms

TermDefinition
Surgical capillary wound drain, luminal, synthetic polymerA sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). 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
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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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