FDA UDI
In Commercial Distribution
🇺🇸 United States
Fast Find Grid: Disposable CT Biopsy Grid
DI: 10815112020214
·
Model: 600001
·
BRACCO DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25
Basic Information
- Brand Name
- Fast Find Grid: Disposable CT Biopsy Grid
- Primary DI
- 10815112020214
- Version / Model
- 600001
- Catalog Number
- 600001
- Company Name
- BRACCO DIAGNOSTICS INC
- Labeler DUNS
- 849234661
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3debf30c-31ad-4b8f-9923-f3cb77eaf452
Device Description
Fast Find Grid
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47020 | Imaging lesion localization marker, external, single-use | A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30815112020218 | GS1 | Sleeve | 25 | In Commercial Distribution | |
| Primary | 10815112020214 | GS1 | ||||
| Package | 50815112020212 | GS1 | Sleeve | 1500 | In Commercial Distribution | |
| Unit of Use | 00815112020217 | GS1 |
Customer Contacts
- Phone
- 609-514-2200
- [email protected]