AccessGUDID - DEVICE: TenoTac Soft Tissue Fixation System (00889795057181)

GUDID

Device Identifier (DI) Information

Brand Name: TenoTac Soft Tissue Fixation System
Version or Model: P42-122-0075-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P42-122-0075-S
Company Name: PARAGON 28, INC.

Primary DI Number: 00889795057181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: (Medium) TenoTac Female Implant ø4.5mm x 2.2mm x 7.5mm Long Sterile Packaged

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-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 cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone

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
No Device Sizes

Device Record Status

Public Device Record Key: 35513467-0675-4b12-9f9b-a0797fb52c29
Public Version Date: August 15, 2022
Public Version Number: 1
DI Record Publish Date: August 05, 2022