FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277122520
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
8988
Catalog number
8988
Device description
Gray Syringe Assist with Ergonomic Handle
Published
2021-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQGAdaptor, Holder, Syringe
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277122520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277122520008402771225208402771225200840277122520

GMDN Terms#

Term, Definition table
TermDefinition
Syringe dispensing gun, reusableA hand-held, manually-operated device intended to facilitate the infusion/dispensing of a high viscosity fluid or pressurized liquid (e.g., laminar stream) by assisting with the advancement of the syringe plunger. It includes a manually-squeezed lever mechanism (e.g., pistol-like) and is designed to accept a standard syringe (not included) whereby it is intended to increase the amount of force the user can apply to the syringe plunger based on leverage. It is not foot-operated and does not include a rotating crank mechanism. 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

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Primary DI, Brand, Company table
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00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
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00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
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00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
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00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29