AccessGUDID - DEVICE: Biliary Plastic Stent Introducer (06932503513937)

GUDID

Device Identifier (DI) Information

Brand Name: Biliary Plastic Stent Introducer
Version or Model: BPDI-1040/22
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503513937
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: 10Fr Introducer diameter,40cm Max length of plastic stent can be introduced,2200mm Working length

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	Stents, Drains And Dilators For The Biliary Ducts

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230127	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
Outer Diameter: 3.3 Millimeter
Length: 220 Centimeter

Device Record Status

Public Device Record Key: e80f02c7-156c-4667-8dfe-17b6d77d1147
Public Version Date: October 10, 2024
Public Version Number: 3
DI Record Publish Date: November 30, 2023