AccessGUDID - DEVICE: SynFix-LR (10705034722153)

GUDID

Device Identifier (DI) Information

Brand Name: SynFix-LR
Version or Model: 03.802.020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03802020
Company Name: SYNTHES (U.S.A.) LP

Primary DI Number: 10705034722153
Issuing Agency: GS1
Commercial Distribution End Date: September 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 832637081 *Terms of Use

Device Description: AIMING DEVICE FOR 12MM SYNFIX-LR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47815	Orthopaedic implant aiming/guiding block, reusable	A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, surgical, instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49b8cf0f-315c-45ec-bf52-af0dc89d396c
Public Version Date: September 17, 2020
Public Version Number: 4
DI Record Publish Date: December 31, 2016