Identity
- Trade Name
- BAMBINO-TIES FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- ASSORTED PACK - BAMBINO LIG TIES FDA UDI
- Model / Reference
- BTAS84 FDA UDI
- Description
- ASSORTED PACK - BAMBINO LIG TIES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886101773 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic archwire/bracket ligature 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic archwire/bracket ligature
A single-use orthodontic archwire/legature designed to securely tether an orthodontic archwire to an orthodontic bracket or hold the archwire in the archwire slot of an orthodontic bracket (or brace).
Similar devices
Also classified as Orthodontic archwire/bracket ligature.
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- Mini Stix Ligature Ties — TP ORTHODONTICS, INC. · Class I
- MINI-TIES — Ortho Organizers, Inc. · Class I
- Plak Smacker — Young Innovations, Inc. · Class I
- PHOENIX — AURADONICS INC. · Class I
- Plak Smacker — Young Innovations, 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 |
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Manufacturer
- Manufacturer
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI a2217da9-848f-4460-a148-320c6f039e8d 34 fields · synced Jul 18, 2026