FDA.report

NA

Primary DI
03596010038036
Brand
NA
Company
Smith & Nephew, Inc.
Model
111169
Catalog number
111169
Device description
MEDIAL CHISEL/DRILL GUIDE FOR KRACKOW HTO BLADE STAPLE
Published
2015-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZXGuide, surgical, instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010038036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010038036035960100380363596010038036

GMDN Terms

TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800200200079Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
08800200200086Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
00889024706965PSN 10MM M/L SHIFT BLOCKZimmer, Inc.FZX2026-03-19
03662663143462MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143479MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143486MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143493MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143509MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143516MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143523MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143530MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
00763000885212n/aMEDTRONIC SOFAMOR DANEK, INC.FZX2026-03-16
00840277133410Innomed, Inc.INNOMED, INC.FZX2026-03-11
10705034578866N/AMedos International SàrlFZX2026-03-05
10705034578873N/AMedos International SàrlFZX2026-03-05
10705034578880N/AMedos International SàrlFZX2026-03-05
10705034578897N/AMedos International SàrlFZX2026-03-05
00841435120402TecometTECOMET INC.FZX2026-02-27
09421038411889Adj Dist Fem Alignment Guide – CartilageENZTEC LIMITEDFZX2026-02-27
09421038411896Adj Dist Fem Alignment Guide – PaddleENZTEC LIMITEDFZX2026-02-27
09421038411902Sagittal Alignment Connector - PivotENZTEC LIMITEDFZX2026-02-27
09421038411919Sagittal Alignment Connector - Pivot with FanENZTEC LIMITEDFZX2026-02-27
09421038411926Dist Fem Cut Block Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411933Dist Fem Cut Block Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
09421038411995IM Rod – 8mm x 135mmENZTEC LIMITEDFZX2026-02-27