AccessGUDID - DEVICE: PONTiS Flexor Tendon Repair System (00859210006032)

GUDID

Device Identifier (DI) Information

Brand Name: PONTiS Flexor Tendon Repair System
Version or Model: 401-3006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 401-3006
Company Name: PONTIS ORTHOPAEDICS, LLC

Primary DI Number: 00859210006032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047775061 *Terms of Use

Device Description: PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures. 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?
13904	Metallic suture, multifilament	A multiple-strand (multifilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081060	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
No Device Sizes

Device Record Status

Public Device Record Key: 8277592a-2da5-4f7b-99c3-18532c572e1d
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: September 01, 2016