FDA.reportPublic FDA data

NA

Primary DI
10886982195104
Brand
NA
Company
Synthes GmbH
Model
355.62
Catalog number
35562
Device description
DIRECTION FINDER
Published
2017-02-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982195104PrimaryGS10
H679355620SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698219510410886982195104

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810056993139corraCarlsmed, Inc.FZX2026-01-30
00810112590036MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590043MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590050MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590067MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590098MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590104MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590128MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590135MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590142MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590180MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590197MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590203MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590210MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590227MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590234MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590241MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590258MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590265MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590272MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590289MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590319MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590326MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590333MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590357MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590364MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590371MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05