FDA UDI
In Commercial Distribution
🇺🇸 United States
PATTERSON D-SPEED
DI: H66518200P1
·
Model: 18200
·
Flow X Ray Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
150
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Basic Information
- Brand Name
- PATTERSON D-SPEED
- Primary DI
- H66518200P1
- Version / Model
- 18200
- Company Name
- Flow X Ray Corporation
- Labeler DUNS
- 010016319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 3
- Public Version Date
- 2023-06-28
- Public Version Status
- Update
- Public Device Record Key
- dd91d437-fd44-4a8e-902e-bd2e0e3de1f2
Device Description
D SPEED ADULT SIZE 2 FILM. 150 FILMS PER BOX
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 | H66518200P1 | HIBCC | ||||
| Unit of Use | H66518200P0 | HIBCC |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 21 Degrees Celsius