FDA UDI
In Commercial Distribution
🇺🇸 United States
Troposphere
DI: H65810001171
·
Model: 1000117
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Troposphere
- Primary DI
- H65810001171
- Version / Model
- 1000117
- Catalog Number
- 1000117
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2022-09-19
- Public Version Status
- Update
- Public Device Record Key
- 04e88254-c185-43a2-90cc-0cc64d86602b
Device Description
Troposphere Powder Fine Cut
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 | H65810001171 | HIBCC | ||||
| Unit of Use | H65810001178 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951865 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 5 | Milligram | |
| Device Size Text, specify | Dental Alloy Powder 5 Toz Pkg |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool well-ventilated place