Identity
- Trade Name
- Archimedes Access Kit FDA UDI
- Generic Name
- Lung biopsy procedure kit FDA UDI
- Device Name
- A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. w/o Syringe FDA UDI
- Model / Reference
- 10009-9 FDA UDI
- Description
- A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. w/o Syringe FDA UDI
Identifiers
- Catalog Number
- 10009-9 FDA UDI
- Primary DI / UDI-DI
- 00856571007296 FDA UDI
- 510(k) Number
- K131234 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Lung biopsy procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Lung biopsy procedure kit
Archimedes Access Kit by Broncus Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lung biopsy procedure kit.
Cleared under the same submission
K131234 also covers:
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 |
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Manufacturer
- Manufacturer
- Broncus Medical Inc.
Sources (1)
- FDA UDI 1946f4fc-a0f0-411d-9851-2f0a6b22993e 37 fields · synced Jun 8, 2026