FDA.report

Bioseal Inc.

Primary DI
10630094024469
Brand
Bioseal Inc.
Company
BIOSEAL
Model
02-446/20
Device description
Magill Catheter Forceps
Published
2023-06-26
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
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094024469PackageGS120In Commercial Distribution
00630094024462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009402446910630094024469
00630094024462006300940244626300940244620630094024462

GMDN Terms

TermDefinition
Intravascular extraction catheter-forcepsA long, thin flexible tube containing retractable forceps (grasping arms) intended to be inserted into the vasculature (artery/vein) to manually grasp and remove unintentionally-introduced foreign bodies (e.g., sheared cannula tips). Its use is typically indicated as an emergency measure during a cardiovascular procedure (e.g., cardiac catheterization), and it is typically operated under fluoroscopic control through the introduction site/instruments for the procedure. The handle of the device includes controls for operating the forceps and typically an extra port for flushing. 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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10630094061525Bioseal Inc.6152/502024-01-29
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