FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00763000825652
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX1222007
Device description
UTERINE CURETTE EX1222007 SMALL
Published
2023-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZSCURETTE, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000825652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000825652007630008256527630008256520763000825652

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169839397INFINITY™ Occipitocervical Upper Thoracic System36070052018-06-10
00199150082780Medtronic Reusable InstrumentsX02260232026-07-04
00199150082797Medtronic Reusable InstrumentsX02260242026-07-04
00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy System43612052026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy System4361203002026-06-26
00643169190542CLYDESDALE PTC™ Spinal System49868402016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9147092060Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092120Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092130Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092140Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096460Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096470Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096520Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096550Surgical DirectSurgical Direct, Inc.FZS2026-07-09
07640139342119ROMEO 2 INSTRUMENTATIONSpineArt SAFZS2025-11-10
04046963939588NOVOCARTAesculap AGFZS2020-04-24
04046963315511NOVOCARTAesculap AGFZS2020-04-23
04046963315528NOVOCARTAesculap AGFZS2020-04-23
10649111094002SklarSKLAR CORPORATIONFZS2019-08-26
10649111094088SklarSKLAR CORPORATIONFZS2019-08-26
10649111217210SklarSKLAR CORPORATIONFZS2019-03-15
10649111217494SklarSKLAR CORPORATIONFZS2019-03-15
10649111217586SklarSKLAR CORPORATIONFZS2019-03-15
10649111217838SklarSKLAR CORPORATIONFZS2019-03-15
10649111017711SklarSKLAR CORPORATIONFZS2019-03-13
10649111017858SklarSKLAR CORPORATIONFZS2019-03-13
10649111018084SklarSKLAR CORPORATIONFZS2019-03-13
10649111018282SklarSKLAR CORPORATIONFZS2019-03-13
10649111018619SklarSKLAR CORPORATIONFZS2019-03-13
10649111161612SklarSKLAR CORPORATIONFZS2019-03-13
10649111161964SklarSKLAR CORPORATIONFZS2019-03-13
10649111162060SklarSKLAR CORPORATIONFZS2019-03-13