FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Capintec Syringe Shield
DI: 00859942006201
·
Model: 511 C-Tec Syringe Shield, 5 cc
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Capintec Syringe Shield
- Primary DI
- 00859942006201
- Version / Model
- 511 C-Tec Syringe Shield, 5 cc
- Catalog Number
- 0665-2020
- Company Name
- Mirion Technologies (capintec), Inc.
- Labeler DUNS
- 047684501
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-28
- Public Version
- 3
- Public Version Date
- 2024-04-08
- Public Version Status
- Update
- Public Device Record Key
- 0ff17ae7-ca59-455f-bc18-7e9a30de0628
- Distribution End Date
- 2022-07-01
Device Description
511 C-Tec Syringe Shield, 5 cc
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWR | Holder, Syringe, Lead | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38379 | Syringe radiation shield | A radiation protective device made to surround a syringe while radioactive material is drawn up into the syringe and during patient injection. It is intended to shield the user from unnecessary exposure to radiopharmaceuticals or other radioactive material used in diagnostic or therapeutic procedures. It is typically made of lead (Pb), lead with a leaded glass insert, or clear lead-equivalent plastic materials. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859942006201 | GS1 |
Customer Contacts
- Phone
- 2018259500
- [email protected]