AccessGUDID - DEVICE: R2 (10653405001195)

GUDID

Device Identifier (DI) Information

Brand Name: R2
Version or Model: 32-170555
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 32-170555
Company Name: Conmed Corporation

Primary DI Number: 10653405001195
Issuing Agency: GS1
Commercial Distribution End Date: October 13, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: R2 MULTIFUNCTION ELECTRODE ACCESSORIES, HEWLETT PACKARD CODEMASTER TO R2 MULTIFUNCTION ADAPTER

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
37423	Pin-indexed adaptor, reusable	A connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDD	Dc-defibrillator, low-energy, (including paddles)

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: No
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: d538a236-00fc-496b-ab90-cae4c5490623
Public Version Date: October 14, 2020
Public Version Number: 3
DI Record Publish Date: October 24, 2015