FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
DI: 40889978792128
·
Model: DIRECTVIEW CR Mammography Cassette with EHR-M Screen
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DIRECTVIEW CR Mammography Cassette with EHR-M Screen
- Primary DI
- 40889978792128
- Version / Model
- DIRECTVIEW CR Mammography Cassette with EHR-M Screen
- Catalog Number
- 8792129
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 88ef6d9e-779a-448b-96e6-eac8ccc6182d
- Distribution End Date
- 2018-03-15
Device Description
DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| MUE | Full field digital,system,x-ray,mammographic | Radiology | 892.1715 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44825 | Digital imaging cassette/storage phosphor screen, mammographic | A combination device for mammography applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic mammography x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the mammography x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60889978792122 | GS1 | Case | 4 | Not in Commercial Distribution | 2018-03-14 |
| Primary | 40889978792128 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080018 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius