FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040036539
·
Model: 1125632
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040036539
- Version / Model
- 1125632
- Catalog Number
- 1125632
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-09-25
- Public Version
- 2
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- dae7c15b-eb31-4145-b922-992e70a07c3d
Device Description
Paper Ultrasound Video Stndard
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSF | RECORDER, PAPER CHART | Cardiovascular | 870.2810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63183 | Medical printer film | A thin transparent film intended to be used with an appropriate printer to produce a hard copy of a medical image generated by a digital diagnostic radiological system [during, e.g., angiography, magnetic resonance imaging (MRI), nuclear medicine, ultrasound (US), computed tomography (CT)]; it is not photographically light sensitive. It is intended to assist high-quality diagnostic evaluation and is used as a hard-copy alternative to, e.g., medical printer paper or photographically sensitive x-ray film. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20304040036536 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10304040036539 | GS1 | ||||
| Unit of Use | 00304040036532 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 38 Degrees Celsius