AccessGUDID - DEVICE: PONTiS Flexor Tendon Repair System (00859210006025)

GUDID

Device Identifier (DI) Information

Brand Name: PONTiS Flexor Tendon Repair System
Version or Model: 400-3031
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400-3031
Company Name: PONTIS ORTHOPAEDICS, LLC

Primary DI Number: 00859210006025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047775061 *Terms of Use

Device Description: PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.

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
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
MBI	Fastener, Fixation, Nondegradable, Soft Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101126	000
K133579	000

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
Length: 4.5 Millimeter
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: 8e342132-b741-4037-aad3-af0e366c7ece
Public Version Date: March 21, 2019
Public Version Number: 5
DI Record Publish Date: September 01, 2016