AccessGUDID - DEVICE: UNIVERSAL PLUS/FLOVAC (30653405011402)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSAL PLUS/FLOVAC
Version or Model: 60-6001-105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-6001-105
Company Name: Conmed Corporation

Primary DI Number: 30653405011402
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITHOUT SIDE HOLES, CANNULA 10MM X 32CM

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:	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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960562	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 10 Millimeter
Length: 32 Centimeter

Device Record Status

Public Device Record Key: 7b1d20a5-dbb3-444c-9f53-f36d748f111a
Public Version Date: June 07, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016