Identity
- Trade Name
- AURA FDA UDI
- Generic Name
- Intracranial pressure monitor FDA UDI
- Device Name
- AURA™ Monitor Pack FDA UDI
- Model / Reference
- TK101 FDA UDI
- Description
- AURA™ Monitor Pack FDA UDI
Identifiers
- Catalog Number
- TK101 FDA UDI
- Primary DI / UDI-DI
- 00860011785217 FDA UDI
- 510(k) Number
- K172209 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracranial pressure monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Intracranial pressure monitor
Aura by Branchpoint & Aura Development LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K172209 also covers:
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Branchpoint & Aura Development LLC
Sources (1)
- FDA UDI c85462b7-63f0-4411-ad89-0ff647ab7453 37 fields · synced Jun 8, 2026