FDA.report

Innomed, Inc.

Primary DI
00840277124944
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
8075-02
Catalog number
8075-02
Device description
McMaster Medullary Canal Aspirator Guide Wire
Published
2020-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840277124944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277124944008402771249448402771249440840277124944

GMDN Terms

TermDefinition
Cannula clampA hand-held manual instrument designed to grasp or compress a cannula. The compression may progress to the point that the cannula is no longer patent. The device is frequently used for temporary partial or complete closing of the cannula in procedures such as cardiopulmonary bypass, haemodialysis, and oral surgery. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
878427491
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
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