FDA UDI
In Commercial Distribution
🇺🇸 United States
SCHWERT
DI: E8965309F0
·
Model: 5309-F
·
A. Schweickhardt GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCHWERT
- Primary DI
- E8965309F0
- Version / Model
- 5309-F
- Catalog Number
- 5309-F
- Company Name
- A. Schweickhardt GmbH & Co. KG
- Labeler DUNS
- 341195628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-07
- Public Version
- 2
- Public Version Date
- 2024-03-01
- Public Version Status
- Update
- Public Device Record Key
- 4b8c8455-de37-4588-89af-d1bdca9c2a18
Device Description
Ligature pliers WEINGART Crovana 13 cm serrated, max. 0,7 mm / .028" carbide coated, SCREW LOCK
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
- Yes
- 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 |
|---|---|---|---|---|
| JEX | PLIER, ORTHODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32874 | Wire holding/twisting pliers | A heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E8965309F0 | HIBCC |
Customer Contacts
- Phone
- +49746498910700
- [email protected]