FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277129048
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
8990-GPR
Catalog number
8990-GPR
Device description
Distractor Groin Pad Cross Bar
Published
2023-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277129048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277129048008402771290488402771290480840277129048

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, externalA hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
878427491
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277133779Innomed, Inc.366236622026-08-18
00840277133786Innomed, Inc.3662-L3662-L2026-08-18
00840277133793Innomed, Inc.4535-EN4535-EN2026-08-18
00840277133724Innomed, Inc.501350132026-07-29
00840277133670Innomed, Inc.366136612026-06-09
00840277133625Innomed, Inc.666066602026-05-29
00840277133632Innomed, Inc.6660-L6660-L2026-05-29
00840277133649Innomed, Inc.6660-R6660-R2026-05-29
00840277133656Innomed, Inc.259625962026-05-29
00840277133663Innomed, Inc.5256-015256-012026-05-29
00840277132505Innomed, Inc.3009-R-D3009-R-D2026-04-24
00840277133618Innomed, Inc.4090-EXT24090-EXT22026-04-21
00840277133458Innomed, Inc.392239222026-04-17
00840277133465Innomed, Inc.2056-012056-012026-04-17
00840277133472Innomed, Inc.2056-022056-022026-04-17
00840277133489Innomed, Inc.2056-032056-032026-04-17
00840277133496Innomed, Inc.2056-042056-042026-04-17
00840277133502Innomed, Inc.2056-062056-062026-04-17
00840277133519Innomed, Inc.2056-072056-072026-04-17
00840277133526Innomed, Inc.2056-082056-082026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24