AccessGUDID - DEVICE: Silicone Y Drainage Tube (04710961934479)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone Y Drainage Tube
Version or Model: 1920-0022
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FORTUNE MEDICAL INSTRUMENT CORP.

Primary DI Number: 04710961934479
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 656763489 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
11307	Biliary T drain	A sterile, T-shaped, tubular device designed to establish a channel for the removal of fluid from a body cavity or anatomical region (usually the biliary tract). It is typically used in conjunction with, or as a component of, a closed drainage system using a low negative pressure through the drain lumen. It is typically made of silicone and has perforations along its distal end; it does not include any fluid collection bags/containers. It comes in various shapes and sizes. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCA	Catheter, Biliary, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980917	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ea5cdc7-b8da-425b-acbc-89b16a61a3c5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 25, 2016