FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277115959
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
3021
Catalog number
3021
Device description
Zell Fixed Angle Wire Guide
Published
2020-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FKCClamp, Cannula
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKCClamp, CannulaGastroenterology, Urology1
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277115959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277115959008402771159598402771159590840277115959

GMDN Terms#

Term, Definition table
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 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
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
00840277133533Innomed, Inc.2056-052056-052026-04-17
00840277133540Innomed, Inc.2056-092056-092026-04-17
00840277133557Innomed, Inc.2056-102056-102026-04-17
00840277133564Innomed, Inc.2056-112056-112026-04-17

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Primary DI, Brand, Company table
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G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
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G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17