AccessGUDID - DEVICE: IvyAIR Meniscus System, Curved (M92847301)

GUDID

Device Identifier (DI) Information

Brand Name: IvyAIR Meniscus System, Curved
Version or Model: 4730
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4730
Company Name: IVY SPORTS MEDICINE LLC

Primary DI Number: M92847301
Issuing Agency: HIBCC
Commercial Distribution End Date: July 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 046226406 *Terms of Use

Device Description: IvyAIR Meniscus Repair System, Curved

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
17735	Arthroscopic suturing unit	A manually-operated, surgical device intended to be used in combination with a compatible arthroscope to mechanically approximate the edges of an internal wound or incision, including muscle tears, with sutures during arthroscopy. A suture punch mechanism places the number of sutures desired by the surgeon at the site of the lesion. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2a876fee-14d0-4bab-8091-bb9440cc715b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 05, 2016