FDA UDI
In Commercial Distribution
🇺🇸 United States
Safco X-Pose intraoral x-ray film
DI: D7231027563
·
Model: 1027563
·
SAFCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
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Basic Information
- Brand Name
- Safco X-Pose intraoral x-ray film
- Primary DI
- D7231027563
- Version / Model
- 1027563
- Catalog Number
- 1027563
- Company Name
- SAFCO DENTAL SUPPLY CO.
- Labeler DUNS
- 020417380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2020-09-08
- Public Version
- 1
- Public Version Date
- 2020-09-16
- Public Version Status
- New
- Public Device Record Key
- eefd10fe-62fc-417a-8dec-21f8bc0860f6
Device Description
Safco X-Pose F58 single 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 40978 | Dental x-ray film, non-screen | A non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It 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 | D72310275633 | HIBCC | Box | 3 | In Commercial Distribution | |
| Primary | D7231027563 | HIBCC | ||||
| Unit of Use | D72310275630 | HIBCC |
Customer Contacts
- Phone
- +1(800)621-2178
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE BTWN 50-70F/10-21C
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 70 Degrees Fahrenheit