Identity
- Trade Name
- Adler MicroMed Laser Surgery Fiber FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- Adler MicroMed Laser Surgery Luer Lock 600 NA 0.37 2.5m FDA UDI
- Model / Reference
- BFCS000302 FDA UDI
- Description
- Adler MicroMed Laser Surgery Luer Lock 600 NA 0.37 2.5m FDA UDI
Identifiers
- Catalog Number
- BFCS000302 FDA UDI
- Primary DI / UDI-DI
- 00850348007243 FDA UDI
- 510(k) Number
- K152417 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Adler MicroMed Laser Surgery Fiber by Adler MicroMed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K152417 also covers:
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laser Surgery Fiber — Adler MicroMed, Inc.
- Adler MicroMed Laster Surgery Fiber — Adler MicroMed, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Adler MicroMed, Inc.
Sources (1)
- FDA UDI 6fa0f555-fa4d-433f-bbc8-e385e0337514 36 fields · synced May 30, 2026