Identity
- Trade Name
- Crossback Acetabular Reamer 43mm EUDAMEDViant Medical, LLC FDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- Crossback Acetabular Reamer 43mm EUDAMEDCROSSBACK ACETABULAR REAMER 43 mm FDA UDI
- Model / Reference
- T17612 EUDAMEDFDA UDI
- Description
- CROSSBACK ACETABULAR REAMER 43 mm FDA UDI
Identifiers
- Catalog Number
- T17612 FDA UDI
- Primary DI / UDI-DI
- 00840096400502 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840096400502 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Acetabular orthopaedic reamer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Estonia 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 43 Millimeter FDA UDI
Category: Bone cutting forceps, reusable
Crossback Acetabular Reamer 43mm by Viant Medical, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone cutting forceps, reusable.
- Gimmi — Gimmi GmbH · Class I
- GLOBAL UNITE — DePuy Ireland UC · Class I
- KNEO FEMORAL CUTTING BLOCK S08 — groupe lépine · Class I
- AG15-0002 — X.NOV MEDICAL TECHNOLOGY · Class I
- SPECIALIST 2 — DePuy Ireland UC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- PED WIRE CUT W/TUNG INSERT SIDE BIT — Tecomet,Inc · Class I
- Saw blade, 0.9/15, L115 - Aesculap — BEZNOSKA, s.r.o. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840096400502 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Viant Medical, LLC
- EUDAMED SRN
- US-MF-000042049
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED d98901ff-db76-4308-8451-7d32231a3d5e 61 fields · synced Jun 17, 2026
- FDA UDI a72b6b73-bc0e-4094-ac04-e116484976ec 35 fields · synced May 30, 2026