FDA UDI
Not in Commercial Distribution
🇺🇸 United States
READYMATIC Fixer and Replenisher
DI: 60889978712878
·
Model: READYMATIC Fixer and Replenisher
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- READYMATIC Fixer and Replenisher
- Primary DI
- 60889978712878
- Version / Model
- READYMATIC Fixer and Replenisher
- Catalog Number
- 8712879
- 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
- 2020-06-08
- Public Version Status
- Update
- Public Device Record Key
- b38edf0b-4470-4abb-b6a8-b6488123297c
- Distribution End Date
- 2020-06-04
Device Description
READYMATIC Fixer and Repl - 4x1GL
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
- 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 |
|---|---|---|---|---|
| IWZ | Film, radiographic | Radiology | 892.1840 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41009 | X-ray film processing chemical, automatic | A chemical, e.g., a fixer or developer, which is necessary for automatic processing of x-ray film or other radiographic films used in, e.g., computed tomography (CT), magnetic resonance (MR), ultrasound or nuclear medicine. This GMDN code will include those chemicals, and in some cases their specialized containers, e.g., prefilled cartridges, designed specifically for use with automatic daylight or darkroom radiographic film processors. | No | Active |
| 41008 | X-ray film processing chemical, manual | A chemical, e.g., a fixer or developer, used in the manual processing of x-ray film or other kinds of radiographic film used in medical applications, e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and nuclear medicine applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60889978712878 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius