FDA UDI
In Commercial Distribution
🇺🇸 United States
Troposphere
DI: H65810011811
·
Model: 1001181
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Troposphere
- Primary DI
- H65810011811
- Version / Model
- 1001181
- Catalog Number
- 1001181
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- 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
- 79b41551-9828-4a7c-92ee-8e2ce393911a
Device Description
Troposphere 1 Spil 400mg 50 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 | H65810011811 | HIBCC | ||||
| Unit of Use | H65810011818 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951865 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 400 | Milligram | |
| Device Size Text, specify | 400mg Dental Amalgam Alloy Self-Activating Capsule |
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