Identity
- Trade Name
- LAZIC FDA UDI
- Generic Name
- Nasal speculum, reusable FDA UDI
- Device Name
- Nasal specula EUDAMEDHARTMANN NASAL SPECULA FIG. 1 TOTAL LENGTH 165 MM / 6 1/2" FDA UDI
- Model / Reference
- 70.595.01 EUDAMEDFDA UDI
- Description
- HARTMANN NASAL SPECULA FIG. 1 TOTAL LENGTH 165 MM / 6 1/2" FDA UDI
Identifiers
- Catalog Number
- 70.595.01 FDA UDI
- Primary DI / UDI-DI
- 04250603738084 EUDAMEDFDA UDI
- Basic UDI-DI
- 42506037-1-0-CI01-N01-GL EUDAMED
- Direct Marketing DI
- 04250603738084 EUDAMED
- FDA Product Code
- KAG FDA UDI
- EMDN Code
- L149004 ENT SPECULUMS, REUSABLE EUDAMED
- GMDN Term
- Nasal speculum, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.1800 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Nasal speculum, reusable
Lazic by Peter Lazic GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Peter Lazic GmbH
Sources (2)
- FDA UDI 6da81d4a-dada-4937-b5ab-7c8d52ec9502 35 fields · synced Jul 15, 2026
- EUDAMED 03f7f69d-cbb5-4582-a238-1eb045d919b4 61 fields · synced Jul 15, 2026