Identity
- Trade Name
- EUROPA FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Stainless Steel, .016 (,41mm), Lower, Europa Form II, Aesthetic FDA UDI
- Model / Reference
- SSEFL116AEX FDA UDI
- Description
- Stainless Steel, .016 (,41mm), Lower, Europa Form II, Aesthetic FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886237656 FDA UDI
- FDA Product Code
- DZC FDA UDI
- GMDN Term
- Orthodontic archwire FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — .016 Inch FDA UDI
Category: Orthodontic archwire
Europa by G&H Wire Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic archwire.
- NITANIUM® RCS STRAIGHT LEGS — Ortho Organizers, Inc. · Class I
- 3M™ Unitek™ — 3M UNITEK CORPORATION · Class I
- Masel — Ortho Organizers, Inc. · Class I
- Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
- remanium® — Dentaurum · Class I
- Wires & Accessories — World Class Technology Corporation · Class I
- RMO — RMO · Class I
- ALPHA-WIRES — Ortho Pro Dent LLC · 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 |
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Manufacturer
- Manufacturer
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI 90ba24c7-4c8d-4aff-a625-a971757c37d4 35 fields · synced Jun 8, 2026