FDA UDI
In Commercial Distribution
🇺🇸 United States
SCHWERT
DI: E8962564500
·
Model: 2564-50
·
A. Schweickhardt GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SCHWERT
- Primary DI
- E8962564500
- Version / Model
- 2564-50
- Catalog Number
- 2564-50
- 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
- 2023-02-22
- Public Version
- 2
- Public Version Date
- 2024-03-29
- Public Version Status
- Update
- Public Device Record Key
- c8a1f19c-70cd-4ad2-9b31-09f722b2a486
Device Description
SURGICAL ASPIRATION 5,0 MM DIAMETER, 175mm Ø 6mm connection WITH ADDITIONAL SLOT AGAINST SUCKING IN
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 |
|---|---|---|---|---|
| KCB | TUBE, TONSIL SUCTION | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38759 | Dental suction system cannula, reusable | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E8962564500 | HIBCC |
Customer Contacts
- Phone
- +49746498910700
- [email protected]