Identity
- Trade Name
- devemed FDA UDI
- Generic Name
- Orthopaedic graft inserter, reusable FDA UDI
- Device Name
- Granulate Plugger 4.5 / 3.5 mm graduated; 8-10-13-15-16-18 mm F-LINE | SL | double ended FDA UDI
- Model / Reference
- 2500-39 F FDA UDI
- Description
- Granulate Plugger 4.5 / 3.5 mm graduated; 8-10-13-15-16-18 mm F-LINE | SL | double ended FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061644023622 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Orthopaedic graft inserter, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic graft inserter, reusable
Developed with precision and safety in mind, the Granulate Plugger 4.5/3.5 mm is a versatile and effective instrument for dental surgeons, allowing them to precisely push cartilage or bone grafts into position during ACL reconstruction surgery.
Similar devices
Also classified as Orthopaedic graft inserter, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- SeaSpine Spacer System - Hollywood — SeaSpine Orthopedics Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- INTRAFIX — DePuy Mitek, Inc. · Class I
- Zavation — ZAVATION · Class II
- Kalitec Disc Prep — Kalitec Direct LLC · Class I
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- Wheelhouse Medical Specials — WHEELHOUSE MEDICAL · 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
- devemed GmbH
Sources (1)
- FDA UDI 49a531ad-feca-41c9-ab94-006aff59d3c5 34 fields · synced Jul 22, 2026