FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CII Transporter II
DI: 00859942006294
·
Model: 0670-2026
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CII Transporter II
- Primary DI
- 00859942006294
- Version / Model
- 0670-2026
- Catalog Number
- 0670-2026
- 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
- 2019-07-01
- Public Version
- 3
- Public Version Date
- 2024-04-08
- Public Version Status
- Update
- Public Device Record Key
- 447341f7-fd57-4c39-8b58-79612f7d6376
- Distribution End Date
- 2022-07-01
Device Description
Shielded Syringe Carrier for PET
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 |
|---|---|---|---|---|
| 40903 | Radiation shielding container, transport/transfer | A radiation protection device specifically designed to shield persons from harmful radiation exposure during air or land based shipping, transfer and delivery of radioactive materials (e.g., radioisotopes) from facility to facility. Designs typically incorporate a container with a lead lining sufficient to attenuate the emissions from the contained radioactive materials, sources, radiopharmaceuticals, or radiation containing devices being transported. This device is used for intra- and inter-hospital transportation of syringes, vials or other devices containing radioisotopes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859942006294 | GS1 |
Customer Contacts
- Phone
- 201-825-9500
- [email protected]