FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040059623
·
Model: 1003048
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040059623
- Version / Model
- 1003048
- Catalog Number
- 1003048
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 1
- Public Version Date
- 2018-10-25
- Public Version Status
- New
- Public Device Record Key
- d6bef996-760e-4778-adfb-647fc1678def
Device Description
Impulse Heat Sealer
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSD | Device, heat-sealing | Hematology | 864.9750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36674 | Package sealing unit | A mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00304040059623 | GS1 |