FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277127471
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
1132-03
Catalog number
1132-03
Device description
Ditmars Straight Carpal Tunnel Probe
Published
2021-06-17
Public version status
New
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277127471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277127471008402771274718402771274710840277127471

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic probeA hand-held manual surgical instrument designed to be inserted through an arthroscope to explore, measure, and/or perform therapeutic procedures within a joint. 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
00199150069675Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-03-20
10705034577449N/AMedos International SàrlHXB2026-03-05
10889981443436SpecialsSeaspine Orthopedics CorporationHXB2026-03-03
10888857578197Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578203Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578630Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578647Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578654Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578661Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578678Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578685Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578692Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578708Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
03662663131551Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131568Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131575Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131582Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131599Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131605Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131612Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
00860014213458Introducer ProbeTETROUS, INC.HXB2026-02-10
00860014213472Pusher ProbeTETROUS, INC.HXB2026-02-10
00860014213496Introducer Probe - SJTETROUS, INC.HXB2026-02-10
00810158218833PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218840PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218857PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218864PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
10889981441531SpecialsSeaspine Orthopedics CorporationHXB2026-01-30
00840180544013General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29
00840180545188General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29