← Back to catalogue
SYRINGE SHLD, PRO-TEC PET, 5cc, HSW
EUDAMEDFDA UDIClass I (EU MDR)
Ref 007-969Model 511 Dose Drawing Syringe Shield, 5cc
Identity
- Trade Name
- SYRINGE SHLD, PRO-TEC PET, 5cc, HSW EUDAMEDPro-Tec PET, 5cc HSW FDA UDI
- Generic Name
- Syringe radiation shield FDA UDI
- Device Name
- Tungsten Syringe Shield with Glass Window for PET FDA UDI
- Model / Reference
- 511 Dose Drawing Syringe Shield, 5cc EUDAMED007-969 EUDAMEDFDA UDI
- Description
- Tungsten Syringe Shield with Glass Window for PET FDA UDI
Identifiers
- Catalog Number
- 007-969 FDA UDI
- Primary DI / UDI-DI
- 00859942006812 EUDAMEDFDA UDI
- Basic UDI-DI
- 08599420061024U EUDAMED
- FDA Product Code
- IWR FDA UDI
- EMDN Code
- Z11029099 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - OTHER EUDAMED
- GMDN Term
- Syringe radiation shield FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SYRINGE SHLD, PRO-TEC PET, 5cc, HSW by Mirion Technologies (Capintec), Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08599420061024U | Class I | Active |
| 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
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 551f36ce-e414-481f-b58e-3f903488d66f 61 fields · synced Aug 5, 2026
- FDA UDI e6294bc4-424e-4a75-b6e2-b6eca5e90130 35 fields · synced May 30, 2026