Identity
- Trade Name
- PK Papyrus FDA UDI
- Generic Name
- Bare-metal coronary artery stent FDA UDI
- Model / Reference
- 3.0/26/140 FDA UDI
Identifiers
- Catalog Number
- 434899 FDA UDI
- Primary DI / UDI-DI
- 07640130447271 FDA UDI
- FDA Product Code
- NIV FDA UDI
- GMDN Term
- Bare-metal coronary artery stent FDA UDI
Classification
- Device Class
- Unclassified 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
MR Conditional FDA UDI
Category: Bare-metal coronary artery stent
PK Papyrus by Biotronik, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal coronary artery stent.
- REBEL™ — Boston Scientific · Class III
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- Integrity — MEDTRONIC, INC. · Class III
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- Cobra PzF — Celonova Biosciences, Inc. · Class III
- Integrity — MEDTRONIC, INC. · Class III
- REBEL™ — Boston Scientific · Class III
- REBEL™ — Boston Scientific · Class III
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA UDI 980945d5-8d77-4adf-b921-dcbd4b334b50 36 fields · synced May 31, 2026