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Eckert & Ziegler Isotope Products, Inc.
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref A3537
Identity
- Trade Name
- Eckert & Ziegler Isotope Products, Inc. FDA UDI
- Generic Name
- Nuclear medicine phantom, flood source FDA UDI
- Device Name
- Flood Sources EUDAMED8" Rectangular Flood Source FDA UDI
- Model / Reference
- A3537 EUDAMEDFDA UDI
- Description
- 8" Rectangular Flood Source FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810117210793 EUDAMEDFDA UDI
- Basic UDI-DI
- 081011721FLJS EUDAMED
- FDA Product Code
- IYQ FDA UDI
- EMDN Code
- Z11029099 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - OTHER EUDAMED
- GMDN Term
- Nuclear medicine phantom, flood source FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1380 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, flood source
Eckert & Ziegler Isotope Products, Inc. by Eckert & Ziegler Isotope Products — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Nuclear medicine phantom, flood source.
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- Pinestar Technology Inc — PINESTAR TECHNOLOGY INC. · Class I
- RadQual — RADQUAL, LLC · 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 a7ace29b-077f-427a-af7f-28a3c07a8a82 33 fields · synced Jul 14, 2026
- EUDAMED 6f5ab89e-8704-487f-b227-af5ed1ded7df 61 fields · synced Jul 14, 2026