AccessGUDID - DEVICE: VERSANAIL®TIBIAL NAIL (00887868018749)

GUDID

Device Identifier (DI) Information

Brand Name: VERSANAIL®TIBIAL NAIL
Version or Model: 1812-10-360
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 181210360
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868018749
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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:	Yes
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?
38152	Tibia nail	A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTN	WASHER, BOLT NUT
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
HWC	Screw, fixation, bone
HTY	PIN, FIXATION, SMOOTH
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
JDW	PIN, FIXATION, THREADED
HRS	PLATE, FIXATION, BONE
LXT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10MM X 36CM

Device Record Status

Public Device Record Key: e56104e6-253f-45fb-a733-54e992e9ccf1
Public Version Date: December 08, 2022
Public Version Number: 5
DI Record Publish Date: October 24, 2015