← Back to catalogue

Advanix™ Pancreatic Stent Kit

FDA UDIEUDAMED

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Advanix™ Pancreatic Stent Kit FDA UDI
Generic Name
Polymeric pancreatic stent, non-bioabsorbable FDA UDI
Device Name
Pancreatic Stent Kit FDA UDI
Model / Reference
M00537530 FDA UDI
Description
Pancreatic Stent Kit FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
08714729856306 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Polymeric pancreatic stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Polymeric pancreatic stent, non-bioabsorbable

Advanix™ Pancreatic Stent Kit by Boston Scientific — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric pancreatic stent, non-bioabsorbable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Scientific

Sources (2)

  • FDA UDI 344ac3ec-11b0-4fb4-a32b-660478f2db95 35 fields · synced May 30, 2026
  • EUDAMED 1 fields · synced May 22, 2026