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Pancreatic Stent

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
PANCREATIC STENT FDA UDI
Generic Name
Polymeric pancreatic stent, non-bioabsorbable FDA UDI
Model / Reference
PBD-234-1006 FDA UDI

Identifiers

Catalog Number
N1076631 FDA UDI
Primary DI / UDI-DI
04953170461194 FDA UDI
510(k) Number
K021672 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

Category: Polymeric pancreatic stent, non-bioabsorbable

Pancreatic Stent by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric pancreatic stent, non-bioabsorbable.

Cleared under the same submission

K021672 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 6f0e93ae-a343-4efe-987c-27dbb2aa0150 35 fields · synced May 30, 2026