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SYRINGE SHIELD, GAARD LOCK, PET, 3cc
EUDAMEDFDA UDIClass I (EU MDR)
Ref 007-711Model 511 Dose Drawing Syringe Shield, 5cc
Identity
- Trade Name
- SYRINGE SHIELD, GAARD LOCK, PET, 3cc EUDAMEDGaard Lock PET 3 cc FDA UDI
- Generic Name
- Syringe radiation shield FDA UDI
- Device Name
- Tungsten Syringe Shield for PET with Flanged Locking Mechanism FDA UDI
- Model / Reference
- 511 Dose Drawing Syringe Shield, 5cc EUDAMED007-711 EUDAMEDFDA UDI
- Description
- Tungsten Syringe Shield for PET with Flanged Locking Mechanism FDA UDI
Identifiers
- Catalog Number
- 007-711 FDA UDI
- Primary DI / UDI-DI
- 00859942006911 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
- France 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 SHIELD, GAARD LOCK, PET, 3cc 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 |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 2727a8a1-b0e4-43c5-9150-57aa8bbf9d1f 61 fields · synced Jun 19, 2026
- FDA UDI 811b8afc-5156-47df-bca0-f5f7588d44a4 35 fields · synced May 30, 2026