AccessGUDID - DEVICE: TENOLOK, HI-FI (20653405987168)

GUDID

Device Identifier (DI) Information

Brand Name: TENOLOK, HI-FI
Version or Model: T50S65
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T50S65
Company Name: Conmed Corporation

Primary DI Number: 20653405987168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: TenoLok Tenodesis Kit with 5.0 mm TenoLok Anchor with One #2 Hi-Fi Suture, 2.4 mm Guide Pin, and 6.5 mm Drill Bit

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:	Yes
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?
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MBI	Fastener, fixation, nondegradable, soft tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120841	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5.0 MM ANCHOR
Device Size Text, specify: 2.4MM GUIDE PIN
Device Size Text, specify: 6.5MM DRILL BIT

Device Record Status

Public Device Record Key: 06440799-33f7-4b4a-a978-a92ff63ee5a0
Public Version Date: August 07, 2024
Public Version Number: 2
DI Record Publish Date: February 03, 2021