AccessGUDID - DEVICE: Davol® Hysterectomy T-Drain, Stem, Perforated Crossbar (00801741018701)

GUDID

Device Identifier (DI) Information

Brand Name: Davol® Hysterectomy T-Drain, Stem, Perforated Crossbar
Version or Model: 0070450
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0070450
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741018701
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Davol® Hysterectomy T-Drain, Stem, Perforated Crossbar

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):	Yes
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?
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
JOL	CATHETER AND TIP, SUCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 22 French

Device Record Status

Public Device Record Key: ccdd5584-ec9d-4c1a-8bc0-28426e8b6b11
Public Version Date: August 01, 2023
Public Version Number: 3
DI Record Publish Date: August 06, 2016