AccessGUDID - DEVICE: Fluoro Tip ERCP Cannula (08714729193432)

GUDID

Device Identifier (DI) Information

Brand Name: Fluoro Tip ERCP Cannula
Version or Model: M00530980
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729193432
Issuing Agency: GS1
Commercial Distribution End Date: March 18, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: ERCP Cannula-Ultra Tapered Tip

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":	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?
16429	ERCP catheter, non-balloon, non-electrical, single-use	A non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODD	Endoscopic retrograde cholangiopancreatography (ERCP) cannula

FDA Premarket Submission

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

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
Device Size Text, specify: 0.64 mm Diameter
Device Size Text, specify: 0.025 in Diameter

Device Record Status

Public Device Record Key: db71dae4-d578-4b19-844e-5e3711f0db9a
Public Version Date: March 29, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016