FDA UDI
In Commercial Distribution
🇺🇸 United States
STOMA®
DI: ESAM2280251
·
Model: 2280.25
·
Storz am Mark GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- STOMA®
- Primary DI
- ESAM2280251
- Version / Model
- 2280.25
- Catalog Number
- 2280.25
- Company Name
- Storz am Mark GmbH
- Labeler DUNS
- 318268125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-27
- Public Version
- 1
- Public Version Date
- 2020-09-04
- Public Version Status
- New
- Public Device Record Key
- ee08136b-e993-4037-a7f1-914226a0a5b8
Device Description
Amalgam carrier
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKI | CARRIER, AMALGAM, OPERATIVE | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35696 | Dental amalgam carrier | A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | ESAM2280250 | HIBCC | ||||
| Primary | ESAM2280251 | HIBCC |
Customer Contacts
- Phone
- +49746592600
- [email protected]