FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277128058
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
4231-03
Catalog number
4231-03
Device description
Curette Suction for Device Adaptor
Published
2022-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FKCClamp, Cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKCClamp, CannulaGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277128058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277128058008402771280588402771280580840277128058

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
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
00840277133571Innomed, Inc.2056-122056-122026-04-17
00840277133588Innomed, Inc.2056-132056-132026-04-17
00840277133595Innomed, Inc.2056-142056-142026-04-17
00840277133601Innomed, Inc.2056-152056-152026-04-17
00840277132499Innomed, Inc.3009-L-D3009-L-D2025-07-03
00840277132185Innomed, Inc.3001-D3001-D2025-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776376154MillenniumAvalign Technologies, Inc.FKC2023-09-08
00190776190088MillenniumAvalign Technologies, Inc.FKC2021-11-02
00190776190095MillenniumAvalign Technologies, Inc.FKC2021-11-02
00840277114549Innomed, Inc.INNOMED, INC.FKC2020-09-29
00840277115959Innomed, Inc.INNOMED, INC.FKC2020-09-29
00840277120786Innomed, Inc.INNOMED, INC.FKC2020-09-29
00840277124937Innomed, Inc.INNOMED, INC.FKC2020-09-29
10852250006083Lifemed Cannula ClampLIFEMED OF CALIFORNIAFKC2015-10-13