FDA.report

Innomed, Inc.

Primary DI
00840277124012
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
1114-01
Catalog number
1114-01
Device description
Kokani Tissue Elevator Suture/Graft Passer with Slot
Published
2020-02-17
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
HXIPasser, Wire, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840277124012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277124012008402771240128402771240120840277124012

GMDN Terms

TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. 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

Other Devices From This Company

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00840277133427Innomed, Inc.7325-007325-002026-03-20
00840277133403Innomed, Inc.4576-02-564576-02-562026-03-11
00840277133410Innomed, Inc.4576-564576-562026-03-11
00840277133359Innomed, Inc.4535-304535-302026-02-26
00840277133366Innomed, Inc.4535-904535-902026-02-26
00840277133373Innomed, Inc.3440-L3440-L2026-02-26
00840277133380Innomed, Inc.3440-R3440-R2026-02-26
00840277133182Innomed, Inc.2725-EU2725-EU2026-02-06
00840277133199Innomed, Inc.4090-EU4090-EU2026-02-06
00840277133205Innomed, Inc.4095-EU4095-EU2026-02-06
00840277133212Innomed, Inc.4105-EU4105-EU2026-02-06
00840277133229Innomed, Inc.4165-00-EU4165-00-EU2026-02-06
00840277133236Innomed, Inc.8840-EU8840-EU2026-02-06
00840277133243Innomed, Inc.117211722026-02-06
00840277133250Innomed, Inc.117311732026-02-06
00840277133267Innomed, Inc.T1018-KTT1018-KT2026-02-06
00840277133274Innomed, Inc.T1019-KTT1019-KT2026-02-06
00840277133281Innomed, Inc.T1020-KTT1020-KT2026-02-06
00840277133298Innomed, Inc.T1021-KTT1021-KT2026-02-06
00840277133304Innomed, Inc.T1022-KTT1022-KT2026-02-06

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