AccessGUDID - DEVICE: Chole-Cath Biliary Drainage Catheter (H862CCL21250HX0)

GUDID

Device Identifier (DI) Information

Brand Name: Chole-Cath Biliary Drainage Catheter
Version or Model: CCL2-1250HX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CCL2-1250HX
Company Name: URESIL, LLC

Primary DI Number: H862CCL21250HX0
Issuing Agency: HIBCC
Commercial Distribution End Date: February 12, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 12F

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):	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?
10696	Biliary drain	A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FGE	Catheter, Biliary, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923096	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
Catheter Gauge: 12 French
Length: 40 Centimeter

Device Record Status

Public Device Record Key: 1fd6ee1c-fdb8-407b-a80b-2dcb183081ba
Public Version Date: November 19, 2020
Public Version Number: 6
DI Record Publish Date: September 02, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H862CCL21250HX2	4	H862CCL21250HX1	2020-02-12	Not in Commercial Distribution	Shipper
H862CCL21250HX1	5	H862CCL21250HX0	2020-02-12	Not in Commercial Distribution	Dispenser