FDA.reportPublic FDA data

General Instrument

Primary DI
00841132125892
Brand
General Instrument
Company
ORTHOPEDIATRICS CORP.
Model
01-1003-6421
Catalog number
01-1003-6421
Device description
Feeler Probe, Curved
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00841132125892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132125892008411321258928411321258920841132125892

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379Rbremer@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817867021044PNP Femur00-1560-716000-1560-71602026-10-01
00817867021051PNP Femur00-1560-716500-1560-71652026-10-01
00817867021068PNP Femur00-1560-717000-1560-71702026-10-01
00817867021075PNP Femur00-1560-717500-1560-71752026-10-01
00817867021082PNP Femur00-1560-718000-1560-71802026-10-01
00817867021099PNP Femur00-1560-718500-1560-71852026-10-01
00817867021105PNP Femur00-1560-719000-1560-71902026-10-01
00817867021112PNP Femur00-1560-719500-1560-71952026-10-01
00817867021129PNP Femur00-1560-720000-1560-72002026-10-01
00817867021136PNP Femur00-1560-720500-1560-72052026-10-01
00817867021143PNP Femur00-1560-721000-1560-72102026-10-01
00817867021150PNP Femur00-1560-721500-1560-72152026-10-01
00817867021167PNP Femur00-1560-722000-1560-72202026-10-01
00817867021174PNP Femur00-1560-722500-1560-72252026-10-01
00817867021181PNP Femur00-1560-723000-1560-72302026-10-01
00817867021198PNP Femur00-1560-723500-1560-72352026-10-01
00817867021204PNP Femur00-1560-724000-1560-72402026-10-01
00817867021211PNP Femur00-1560-724500-1560-72452026-10-01
00817867021228PNP Femur00-1560-725000-1560-72502026-10-01
00817867021235PNP Femur00-1560-725500-1560-72552026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606191302PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00840606191319PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00850088713558PRINCETONPrinceton Medical Group, Inc.HXB2026-08-14
B382SD9213821020Surgical DirectSurgical Direct, Inc.HXB2026-08-07
B382SD483800190Surgical DirectSurgical Direct, Inc.HXB2026-08-03
B382SD4838920Surgical DirectSurgical Direct, Inc.HXB2026-08-03
00840606191593Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191869Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191876Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840183532383BR Surgical, LLCBR Surgical, LLCHXB2026-07-21
18257200046706FIREBIRD SFS,SPECIAL PRODUCTSOrthofix US LLCHXB2026-07-17
05060267134554FORCECORD Passing ProbeXIROS LTDHXB2026-07-06
06974940307830endophixSuzhou Endophix Co., Ltd.HXB2026-06-23
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800322758151Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800017271095BENCOXCorentec Co., LtdHXB2026-04-10
10888857578197Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578203Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578630Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578647Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578654Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578661Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578678Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578685Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20