FDA UDI
In Commercial Distribution
🇺🇸 United States
LINEAR MC 150
DI: 60889971058942
·
Model: LINEAR MC 150
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LINEAR MC 150
- Primary DI
- 60889971058942
- Version / Model
- LINEAR MC 150
- Catalog Number
- 1058940
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b0353244-8af4-44da-a005-7464cce6242a
Device Description
MOTORIZED COLLIMATOR - CHINA (DR)
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
- No
- 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 |
|---|---|---|---|---|
| IZX | Collimator, manual, radiographic | Radiology | 892.1610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42252 | Manual-aperture-control diagnostic x-ray system collimator, motorized | A standard, diagnostic x-ray beam-limiting and shaping device with a motorized shutter/length adjustment mechanism that requires the operator to manually adjust the collimator shutters or length of the cone prior to an exposure in order to match the size and shape of the x-ray beam to the size of the x-ray cassette in use. Most motorized collimator assemblies include a light-centring device. An X-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60889971058942 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K810598 | 000 |