STOMA®
- Primary DI
- ESAM4214140
- Brand
- STOMA®
- Company
- Storz am Mark GmbH
- Model
- 4214.14
- Catalog number
- 4214.14
- Device description
- Needles, GR, fig.14, doz.
- Published
- 2020-08-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| GDL | NEEDLE, SUTURING, REUSABLE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| ESAM4214140 | Direct Marking | HIBCC | 0 | |
| ESAM4214141 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Suturing needle, reusable | A non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +49746592600 | sam@stoma.de |
Regulatory Flags
- DUNS number
- 318268125
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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