Identity
- Trade Name
- Falcon FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- Falcon 8 mm Reamer FDA UDI
- Model / Reference
- 907001-0800 FDA UDI
- Description
- Falcon 8 mm Reamer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811714034850 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone-resection orthopaedic reamer, single-use
Falcon by Responsive Orthopedics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-resection orthopaedic reamer, single-use.
- RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
- RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Disposable — Biomet Orthopedics, Inc. · Class I
- PANTA® — Newdeal Sas · Class I
- ACETABULAR REAMER EVO 2 Ti CUP D42 mm — HPF SRL · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Tools - UFC — Trimed, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Responsive Orthopedics Llc
Sources (1)
- FDA UDI d58b08fb-6d77-4bba-ad96-54f82ab821c4 33 fields · synced May 31, 2026