AtriCure Window Access SI Retractor
- Primary DI
- 00818354013979
- Brand
- AtriCure Window Access SI Retractor
- Company
- ATRICURE, INC.
- Model
- 001-400-150
- Catalog number
- N/A
- Device description
- Window Access SI Retractor Body, Robotic 120mm
- Published
- 2018-09-23
- 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 |
|---|
| 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 |
|---|
| 00818354013979 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00818354013979 | 00818354013979 | 818354013979 | 0818354013979 |
GMDN Terms
| Term | Definition |
|---|
| Surgical retraction system, reusable | A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 120 | 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
- false
- Serial number
- true
- 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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