FDA UDI
In Commercial Distribution
🇺🇸 United States
STOMA®
DI: ESAM5318051
·
Model: 5318.05
·
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
- ESAM5318051
- Version / Model
- 5318.05
- Catalog Number
- 5318.05
- 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
- 3
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 006f07f2-d152-4250-80cd-228ef3e13179
Device Description
Added piece for wire loop
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 |
|---|---|---|---|---|
| EIS | REMOVER, CROWN | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64422 | Dental prosthesis removal instrument | A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration; some types are referred to as crown spreaders. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | ESAM5318050 | HIBCC | ||||
| Primary | ESAM5318051 | HIBCC |
Customer Contacts
- Phone
- +49746592600
- [email protected]