FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277117618
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
3042
Catalog number
3042
Device description
Stanton Needle Driver
Published
2020-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWBExtractor
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277117618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277117618008402771176188402771176180840277117618

GMDN Terms#

Term, Definition table
TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
878427491
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277133427Innomed, Inc.7325-007325-002026-03-20
00840277133403Innomed, Inc.4576-02-564576-02-562026-03-11
00840277133410Innomed, Inc.4576-564576-562026-03-11
00840277133359Innomed, Inc.4535-304535-302026-02-26
00840277133366Innomed, Inc.4535-904535-902026-02-26
00840277133373Innomed, Inc.3440-L3440-L2026-02-26
00840277133380Innomed, Inc.3440-R3440-R2026-02-26
00840277133182Innomed, Inc.2725-EU2725-EU2026-02-06
00840277133199Innomed, Inc.4090-EU4090-EU2026-02-06
00840277133205Innomed, Inc.4095-EU4095-EU2026-02-06
00840277133212Innomed, Inc.4105-EU4105-EU2026-02-06
00840277133229Innomed, Inc.4165-00-EU4165-00-EU2026-02-06
00840277133236Innomed, Inc.8840-EU8840-EU2026-02-06
00840277133243Innomed, Inc.117211722026-02-06
00840277133250Innomed, Inc.117311732026-02-06
00840277133267Innomed, Inc.T1018-KTT1018-KT2026-02-06
00840277133274Innomed, Inc.T1019-KTT1019-KT2026-02-06
00840277133281Innomed, Inc.T1020-KTT1020-KT2026-02-06
00840277133298Innomed, Inc.T1021-KTT1021-KT2026-02-06
00840277133304Innomed, Inc.T1022-KTT1022-KT2026-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648143EquinoxeExactech, Inc.HWB2026-03-19
10885862660466N/AExactech, Inc.HWB2026-03-19
10885862663214N/AExactech, Inc.HWB2026-03-19
00810158219335PRINCETONPrinceton Medical Group, Inc.HXK2026-03-12
00810158219113PRINCETONPrinceton Medical Group, Inc.HXK2026-03-11
B922F00500380ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWB2026-03-11
04058749027327NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749027457NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749028102NAFehling Instruments GmbH & Co. KGHXK2026-03-05
00841435122574TecometTECOMET INC.HWB2026-02-27
07899258695174Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695181Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695198Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695204Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695211Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695228Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695235Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
03662663131759Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWB2026-02-11
00810158218772PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
00810158218819PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
00840338602497Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338602961Made-To-OrderTORNIER, INC.HWB2026-02-03
B356DF370170American MedicalsAmerican MedicalsHXK2026-01-30
04058749027990NAFehling Instruments GmbH & Co. KGHXK2026-01-28
04058749028003NAFehling Instruments GmbH & Co. KGHXK2026-01-28
00840338607799Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00840338607805Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00889024704008LB Type 1 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704015LZ 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704022LB 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18