AtriCure SI Retractor Blade
- Primary DI
- 00818354014044
- Brand
- AtriCure SI Retractor Blade
- Company
- ATRICURE, INC.
- Model
- 001-400-191
- Device description
- SI Retractor Blade, 40mm W X 30mm L, Angled
- Published
- 2018-09-20
- Public version status
- Update
- 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 |
|---|
| DWS | Instruments, Surgical, Cardiovascular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00818354014044 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00818354014044 | 00818354014044 | 818354014044 | 0818354014044 |
GMDN Terms
| Term | Definition |
|---|
| Surgical retractor/retraction system blade, reusable | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 30 | Millimeter |
| Width | 40 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 006133784
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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