AccessGUDID - DEVICE: Tricera™ Handpiece, Autoclavable (00859273007113)

GUDID

Device Identifier (DI) Information

Brand Name: Tricera™ Handpiece, Autoclavable
Version or Model: R-10011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R-10011
Company Name: RELIGN CORPORATION

Primary DI Number: 00859273007113
Issuing Agency: GS1
Commercial Distribution End Date: June 29, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 080031617 *Terms of Use

Device Description: Shaver Handpiece, Autoclavable

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:	No
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?
53617	Arthroscopic shaver system handpiece, electrically-powered	A handle with attached cutting blade that is a component of an electrically-powered arthroscopic shaver system designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162770	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide

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: 20f84a2f-fff5-4e12-97eb-67ffef7dcb0e
Public Version Date: May 30, 2025
Public Version Number: 6
DI Record Publish Date: February 20, 2020