FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040041014
·
Model: 1125333
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040041014
- Version / Model
- 1125333
- Catalog Number
- 1125333
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2019-04-03
- Public Version
- 1
- Public Version Date
- 2019-04-11
- Public Version Status
- New
- Public Device Record Key
- b0406aa3-b57d-4b03-96fc-7ad664f57162
Device Description
FX-57 Vinyl Packet Size 2
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 |
|---|---|---|---|---|---|---|
| Package | 20304040041011 | GS1 | 1125333 | 50 | In Commercial Distribution | |
| Primary | 10304040041014 | GS1 | ||||
| Unit of Use | 00304040041017 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- CSH uses Humidity Limitation, Protect from heat and radioactive sources, as well as Temperature Limit.