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
00840277133724Innomed, Inc.501350132026-07-29
00840277133717Innomed, Inc.1252-N-R1252-N-R2026-10-09
00840277133915Innomed, Inc.S6000S60002026-10-09
00840277133922Innomed, Inc.191119112026-10-09
00840277133939Innomed, Inc.192119212026-10-09
00840277133946Innomed, Inc.1252-W-R1252-W-R2026-10-09
00840277133953Innomed, Inc.4515100414515100412026-10-09
00840277133960Innomed, Inc.4515100424515100422026-10-09
00840277133977Innomed, Inc.4515100434515100432026-10-09
00840277133984Innomed, Inc.4515100444515100442026-10-09
00840277133991Innomed, Inc.4515100454515100452026-10-09
00840277134004Innomed, Inc.4515100464515100462026-10-09
00840277133779Innomed, Inc.366236622026-08-18
00840277133786Innomed, Inc.3662-L3662-L2026-08-18
00840277133793Innomed, Inc.4535-EN4535-EN2026-08-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446960362DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
00190446960379DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
10840143919350AtriClip® Selection GuideATRICURE, INC.FZX2026-10-09
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810056993139corraCarlsmed, Inc.FZX2026-01-30
00810112590036MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590043MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590050MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590067MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590098MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590104MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590128MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590135MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590142MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590180MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590197MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590203MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590210MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590227MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590234MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590241MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590258MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590265MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590272MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590289MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590319MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590326MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590333MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05