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Eckert & Ziegler Isotope Products, Inc.
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref A3429
Identity
- Trade Name
- Eckert & Ziegler Isotope Products, Inc. FDA UDI
- Generic Name
- Nuclear medicine phantom, line source FDA UDI
- Device Name
- Quality Assurance Sources EUDAMEDQuality Assurance Line Source FDA UDI
- Model / Reference
- A3429 EUDAMEDFDA UDI
- Description
- Quality Assurance Line Source FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810117210199 EUDAMEDFDA UDI
- Basic UDI-DI
- 081011721QAK5 EUDAMED
- FDA Product Code
- IXD FDA UDI
- EMDN Code
- Z11029099 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - OTHER EUDAMED
- GMDN Term
- Nuclear medicine phantom, line source FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1400 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
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
No
FDA UDI
Category: Nuclear medicine phantom, line source
Eckert & Ziegler Isotope Products, Inc. by Eckert & Ziegler Isotope Products — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Nuclear medicine phantom, line source.
- Sanders Medical Products — SANDERS MEDICAL PRODUCTS, INC. · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · 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
- Eckert & Ziegler Isotope Products
Sources (2)
- FDA UDI 07e2f584-244e-41be-b276-21df5359ceb0 33 fields · synced Jul 9, 2026
- EUDAMED b6ebb38d-e1b8-452f-b8a1-3b629aff6cc0 61 fields · synced Jul 9, 2026