Identity
- Trade Name
- G-ARMOR STENT® FDA UDI
- Generic Name
- Bare-metal aortic stent FDA UDI
- Device Name
- G ARMOR GCM030 6.3cm 20mm 6.5cm 16F FDA UDI
- Model / Reference
- 614752 FDA UDI
- Description
- G ARMOR GCM030 6.3cm 20mm 6.5cm 16F FDA UDI
Identifiers
- Catalog Number
- 614752 FDA UDI
- Primary DI / UDI-DI
- 04046955767380 FDA UDI
- PMA Number
- P150028 FDA UDI
- FDA Product Code
- PNF FDA UDI
- GMDN Term
- Bare-metal aortic stent FDA UDI
Classification
- Device Class
- Class III 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 aortic stent
G-Armor Stent® by B Braun Interventional Systems, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal aortic stent.
- AMDS Hybrid Prosthesis ("AMDS") — Artivion, Inc. · Class III
- AMDS Hybrid Prosthesis ("AMDS") — Artivion, Inc. · Class III
- COOK — William Cook Europe ApS · Class III
- AMDS Hybrid Prosthesis ("AMDS") — Artivion, Inc. · Class III
- COOK — William Cook Europe ApS · Class III
- G-ARMOR STENT® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- G-ARMOR STENT® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
Cleared under the same submission
P150028 also covers:
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
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 III | Pending data |
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Manufacturer
- Manufacturer
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI e03fe1d4-2097-4d1a-9958-14837c24d5af 38 fields · synced Jun 1, 2026