FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: H65890042880
·
Model: 9004288
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- H65890042880
- Version / Model
- 9004288
- Catalog Number
- 9004288
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-06-09
- Public Version
- 1
- Public Version Date
- 2020-06-17
- Public Version Status
- New
- Public Device Record Key
- 1fc686de-93cb-4eb8-9cb4-7c33a926b6f0
Device Description
X-Ray Film HSI Half Speed Blue
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
- Yes
- 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 |
|---|---|---|---|---|
| 16937 | Photographic paper | A device prepared from thin sheet of fibrous material that has been specially produced for recording the output of an image in the form of a photograph. Different methods for reproducing the images upon the paper may be utilized. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H65890042881 | HIBCC | 5 | In Commercial Distribution | ||
| Primary | H65890042880 | HIBCC | ||||
| Unit of Use | H65890042889 | HIBCC |