AccessGUDID - DEVICE: Single Use Biliary Drainage Stent V (04953170346934)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Biliary Drainage Stent V
Version or Model: PBD-1032-0812
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170346934
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *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):	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?
43764	Polymeric biliary stent, non-bioabsorbable	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FGE	CATHETER, BILIARY, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103478	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: c075e5bb-d88a-4c08-82cf-58cea8a8ac05
Public Version Date: April 22, 2024
Public Version Number: 7
DI Record Publish Date: September 21, 2016