FDA UDI
In Commercial Distribution
🇺🇸 United States
Gaard Lock PET 10 cc
DI: 00859942006935
·
Model: 007-713
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gaard Lock PET 10 cc
- Primary DI
- 00859942006935
- Version / Model
- 007-713
- Catalog Number
- 007-713
- Company Name
- Mirion Technologies (capintec), Inc.
- Labeler DUNS
- 047684501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-11
- Public Version
- 2
- Public Version Date
- 2022-12-14
- Public Version Status
- Update
- Public Device Record Key
- a568e3dd-4452-4e3d-9e6b-7f2771df7d3c
Device Description
Tungsten Syringe Shield for PET with Flanged Locking Mechanism
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 | 00859942006935 | GS1 |
Customer Contacts
- Phone
- 201-825-9500
- [email protected]