AccessGUDID - DEVICE: NA (10653405003045)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: RTDS48-05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RTDS48-05
Company Name: Conmed Corporation

Primary DI Number: 10653405003045
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: Radiotranslucent 48 Inch Leadwire

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?
35563	Bariatric bed	A mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K945034	000

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: 5bc6dfe0-9c6f-4670-bea5-ba7b81b75486
Public Version Date: October 14, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016