Identity
- Trade Name
- Straight Wire FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- 032 S/S BALL CLASP .063" Ball Dia/1.560" Length 100/Bag FDA UDI
- Model / Reference
- AMC32SS063BCLP100B FDA UDI
- Description
- 032 S/S BALL CLASP .063" Ball Dia/1.560" Length 100/Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- D972AMC32SS063BCLP100T6 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic archwire
Straight Wire by Acme-Monaco Corp. — 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
- TRUEFORM — G&H Wire Company, Inc. · Class I
- 3M™ Unitek™ — 3M UNITEK CORPORATION · Class I
- EUROPA SOLO-PACK — G&H Wire Company, Inc. · Class I
- A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK — G&H Wire Company, Inc. · Class I
- Masel — Ortho Organizers, Inc. · Class I
- Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
- G4 EUROPA NICKEL TITANIUM — G&H Wire Company, Inc. · 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
- Acme-Monaco Corp.
Sources (1)
- FDA UDI 8fe11b5b-3006-448f-88d3-7b4f0ca60377 34 fields · synced Jun 20, 2026