FDA UDI
In Commercial Distribution
🇺🇸 United States
True Speed Bucky
DI: 60889976573754
·
Model: True Speed Bucky
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- True Speed Bucky
- Primary DI
- 60889976573754
- Version / Model
- True Speed Bucky
- Catalog Number
- 6573752
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9fb61f9b-0846-408f-98c7-33a30f48548f
Device Description
R30-17B-S-T BCKY,SENS MDLw/ToshibaKalare
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IXJ | Grid, radiographic | Radiology | 892.1910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40916 | Moving x-ray grid | A component of a diagnostic x-ray system designed as a moving grid to automatically move back and forth in a linear or reciprocating fashion during an x-ray exposure or exposure sequence. It typically consists of lead (Pb) foil strips separated by x-ray transparent (radiolucent) spacers and is used to absorb scatter radiation, eliminate artefacts and improve image contrast. Depending on its design, it moves in 1 or 2 dimensions during an x-ray exposure. Exposures are coordinated at the point in time in which the grid stops to change direction. The motion is used to blur out the shadows cast by the lead strips, and eliminate grid lines from exposed diagnostic x-ray films. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60889976573754 | GS1 |