Identity
- Trade Name
- ELAN 4 FDA UDI
- Generic Name
- Medical device cleaning jet handpiece FDA UDI
- Device Name
- ELAN 4 AIR RINSING ADAPTOR FDA UDI
- Model / Reference
- GB697R FDA UDI
- Description
- ELAN 4 AIR RINSING ADAPTOR FDA UDI
Identifiers
- Catalog Number
- GB697R FDA UDI
- Primary DI / UDI-DI
- 04046964773686 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Medical device cleaning jet handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medical device cleaning jet handpiece
Elan 4 by Aesculap, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device cleaning jet handpiece.
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- AESCULAP — AESCULAP, INC. · Class I
- ELAN 4 — AESCULAP, 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
- Aesculap, Inc.
Sources (1)
- FDA UDI 6e2a8085-f942-475f-8c07-79ec14fa5a5b 35 fields · synced May 30, 2026