FDA.report

Innomed, Inc.

Primary DI
00840277116338
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
8610-02
Catalog number
8610-02
Device description
Incavo Wire Passer
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
00840277116338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277116338008402771163388402771163380840277116338

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

Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10810128462645Nitinol Loop Passer MEDACTAT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-02-09
00841731134769Hintermann Series VILEX LLCHXI2026-01-16
06974940306369endophixSuzhou Endophix Co., Ltd.HXI2025-12-12
06974940306147endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306154endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306161endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306178endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306185endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306192endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306208endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306215endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306222endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306239endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306246endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306253endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306260endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
00889795154033Special InstrumentParagon 28, Inc.HXI2025-11-14
00889795154040Special InstrumentParagon 28, Inc.HXI2025-11-14
00889795154057Special InstrumentParagon 28, Inc.HXI2025-11-14
00889795154064Special InstrumentParagon 28, Inc.HXI2025-11-14
03662663086271LineSiderHighridge Medical, LLCHXI2025-10-03
03662663087834LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093262LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093378LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093385LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093392LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093408LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093453LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093712LineSiderHighridge Medical, LLCHXI2025-10-03
03662663093729LineSiderHighridge Medical, LLCHXI2025-10-03