Multi-Use Handle M8
FDA UDIEUDAMEDClass I (US FDA UDI)
by Hpf Srl
Identity
- Trade Name
- VÍCEÚČELOVÁ RUKOJEŤ M8 EUDAMEDMULTI-USE HANDLE M8 FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Model / Reference
- H0050056599 EUDAMEDFDA UDIMulti-use handle EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968713574 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968713574 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument handle, non-torque-limiting
Multi-Use Handle M8 by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument handle, non-torque-limiting.
- SpineTune TL — Ldr Spine USA · Class I
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Fusion Taper Remover Screw Grip — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- IDOL — İDOL HASTANE ÜRÜN. SAN. VE TİC. A.Ş. · Class I
- Tecomet — Tecomet,Inc · Class I
- Equinoxe — Exactech, Inc. · Class II
- Kinectiv® — Zimmer, Inc. · Class I
- CUSTOM U JOINT DRIVER — Zimmer, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| 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
- Hpf Srl
Sources (2)
- FDA UDI 48dde4b5-c980-4a63-8fb6-72b33f693576 32 fields · synced Jul 28, 2026
- EUDAMED 65620c88-1213-4a4a-a2b2-71cc99808d74 61 fields · synced Jul 28, 2026