FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Silver D Film
DI: H665182001
·
Model: 18200
·
Flow X Ray Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
Basic Information
- Brand Name
- Silver D Film
- Primary DI
- H665182001
- Version / Model
- 18200
- Catalog Number
- 18200
- Company Name
- Flow X Ray Corporation
- Labeler DUNS
- 010016319
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 5
- Public Version Date
- 2023-06-28
- Public Version Status
- Update
- Public Device Record Key
- c8f49cdc-cf2a-4705-b3e3-ebeda1176191
- Distribution End Date
- 2023-06-22
Device Description
Adult size D x-ray film in vinyl packets. 150 per box, FILM DV-58 SILVER D ADULT VALUE PAK
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | H665182001 | HIBCC | ||||
| Unit of Use | H665182000 | HIBCC | ||||
| Secondary | 00812045030177 | GS1 |