AccessGUDID - DEVICE: Phantom FT™ Biocomposite (00846832060719)

GUDID

Device Identifier (DI) Information

Brand Name: Phantom FT™ Biocomposite
Version or Model: SMB000425
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SMB000425
Company Name: TORNIER, INC.

Primary DI Number: 00846832060719
Issuing Agency: GS1
Commercial Distribution End Date: December 14, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 968990812 *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":	Yes
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?
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.5 Millimeter

Device Record Status

Public Device Record Key: dc14aa09-dd1c-4755-94d8-3847e8b7644a
Public Version Date: March 25, 2022
Public Version Number: 7
DI Record Publish Date: October 16, 2015