Identity
- Trade Name
- ELASTIC ATTACHERS EUDAMEDFDA UDI
- Generic Name
- Orthodontic elastomeric appliance pusher FDA UDI
- Device Name
- Dental Hand Instrument EUDAMEDELASTIC ATTACHERS - GLOW FDA UDIELASTIC ATTACHERS FDA UDI
- Model / Reference
- 402-010 EUDAMEDFDA UDI402-011G FDA UDI
- Description
- ELASTIC ATTACHERS - GLOW FDA UDIELASTIC ATTACHERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707057213 EUDAMEDFDA UDI00190707057237 FDA UDI
- Basic UDI-DI
- 0190707O2ElastAttachersZP EUDAMED
- Unit of Use DI
- 10190707057210 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic elastomeric appliance pusher FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Category: Orthodontic elastomeric appliance pusher
Elastic Attachers by Ortho Organizers, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic elastomeric appliance pusher.
- Ortho Technology — ORTHO TECHNOLOGY, INC. · Class I
- Young Specialties — Young Innovations, Inc. · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- ELASTIC ATTACHERS — Ortho Organizers, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ortho Organizers, Inc.
Sources (3)
- FDA UDI 01b0f3a5-6340-4c11-9f9a-c1e671dcdaf6 33 fields · synced Jul 17, 2026
- FDA UDI 46715d61-8534-4c95-b265-0a891ed7b37f 33 fields · synced May 30, 2026
- EUDAMED 6b9471f9-6728-45a8-a8b2-fd864137ae7f 61 fields · synced Jul 17, 2026