AccessGUDID - DEVICE: TENOLOK (10845854044711)

GUDID

Device Identifier (DI) Information

Brand Name: TENOLOK
Version or Model: T60A80
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: T60A80
Company Name: Conmed Corporation

Primary DI Number: 10845854044711
Issuing Agency: GS1
Commercial Distribution End Date: February 03, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: T60A80 TenoLok Tenodesis Kit with 6.0 mm TenoLok Anchor with One No. 2 Hi-Fi Suture, 2.4 mm Guide Pin, and 8.0 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:	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?
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: 6.0 MM ANCHOR
Device Size Text, specify: 8.0MM DRILL BIT
Device Size Text, specify: 2.4MM GUIDE PIN

Device Record Status

Public Device Record Key: 1ff10bd6-ef7b-4625-bdff-488368da480a
Public Version Date: February 03, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016