AccessGUDID - DEVICE: SYSTEM 1200 (30653405043342)

GUDID

Device Identifier (DI) Information

Brand Name: SYSTEM 1200
Version or Model: 60-8054-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-8054-001
Company Name: Conmed Corporation

Primary DI Number: 30653405043342
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SYSTEM 1200 "Y" 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?
35897	Pin-indexed adaptor, single-use	A connecting device designed 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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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: fcdd16bc-8540-4bf8-845c-674f914f244b
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016