FDA UDI
In Commercial Distribution
🇺🇸 United States
X-OMAT 2 Dental Duplicating
DI: 40889971753188
·
Model: X-OMAT 2 Dental Duplicating
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- X-OMAT 2 Dental Duplicating
- Primary DI
- 40889971753188
- Version / Model
- X-OMAT 2 Dental Duplicating
- Catalog Number
- 1753185
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- 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
- 72a10871-d19d-4a37-8e6f-336c13426bc6
Device Description
X-OMAT 2 Dental DUP 50SH 8x10in film
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 40980 | Medical x-ray film, non-screen | A non-screen x-ray film specifically designed for use in medical imaging applications. Non-screen x-ray film is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60889971753182 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 40889971753188 | GS1 | ||||
| Unit of Use | 00889971753180 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- Low: 30 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius