FDA UDI
In Commercial Distribution
🇺🇸 United States
Ionosphere
DI: H65810021531
·
Model: 1002153
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Ionosphere
- Primary DI
- H65810021531
- Version / Model
- 1002153
- Catalog Number
- 1002153
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2022-10-03
- Public Version Status
- Update
- Public Device Record Key
- 855ba3dd-59e5-4e81-aff4-d2372b184a70
Device Description
Ionosphere 2 Spill 600mg Fast Set 500 jar
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
- No
- 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 |
|---|---|---|---|---|
| EJJ | Alloy, amalgam | Dental | 872.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16367 | Dental amalgam | A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H65810021531 | HIBCC | ||||
| Unit of Use | H65810021538 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K821222 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 600mg Dental Amalgam Alloy Self-Activating Capsule | ||
| Weight | 600 | Milligram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool well-ventilated place
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 25 Degrees Celsius