Identity
- Trade Name
- SOFT DISPOSABLE TIPS FDA UDI
- Generic Name
- Ear speculum, single-use FDA UDI
- Model / Reference
- 40 x 3 mm FDA UDI
Identifiers
- Catalog Number
- B-000.11.141 FDA UDI
- Primary DI / UDI-DI
- 04053755114061 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Ear speculum, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ear speculum, single-use
Soft Disposable Tips by Heine Optotechnik GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ear speculum, single-use.
- JEDMED — JEDMED Instrument Company · Class I
- KaWe — Medical, Inc. · Class I
- JEDMED — JEDMED Instrument Company · Class I
- OtoSight Speculum Tip Combination Package — Photonicare, Inc. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- CFM Technologies — C F M TECHNOLOGIES INC · Class I
- CFM Technologies — C F M TECHNOLOGIES INC · Class I
- Medline — MEDLINE INDUSTRIES, 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
- Heine Optotechnik GmbH & Co. KG
Sources (1)
- FDA UDI cde221c1-a7cb-4500-a17a-e365100a50e8 34 fields · synced May 30, 2026