← Back to catalogue
SPH SCREWDRIVER HEX. 3, 5 mm CONN. ZIMMER
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 9084.20.320Model Screwdriver hex. conn. Zimmer
by Hpf Srl
Identity
- Trade Name
- SPH ŠROUBOVÁK ŠEST. 3,5 mm EUDAMEDSPH SCREWDRIVER HEX. 3,5 mm CONN. ZIMMER FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Model / Reference
- 9084.20.320 EUDAMEDFDA UDIScrewdriver hex. conn. Zimmer EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968719156 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968719156 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
SPH SCREWDRIVER HEX. 3, 5 mm CONN. ZIMMER by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 aaf1f74e-85e1-4b28-becc-12a6d302efa8 32 fields · synced Jul 21, 2026
- EUDAMED ba0e9b23-ad7a-4025-8dfb-caf8717cfab3 61 fields · synced Jul 21, 2026