Extra Long/Deep Instrument Set
- Primary DI
- 00840199544868
- Brand
- Extra Long/Deep Instrument Set
- Company
- KOROS U.S.A., INC.
- Model
- 9950-00
- Catalog number
- 9950-00
- Device description
- Extra Long/Deep Instrument Set Consists of the Following: 1 x 9952-10, 1 x 9952-20, 1 x 9952-30, 1 x 9952-40, 1 x 9954-20, 1 x 9954-10, 2 x 9956-10, 2 x 9956-20, 2 x 9958-10, 3 x 9958-20, 1 x 9958-30, 1 x 9958-40, 1 x 9958-50, 2 x 9960-10, 2 x 9960-20, 2 x 9960-30, 2 x 9960-40, 2 x 9960-50, 2 x 9962-10, 2 x 9962-20, 1 x 9964-10, 2 x 9964-20, 2 x 9964-30, 2 x 9964-40, 1 x 9966-10 & 1 x 9968-50
- Published
- 2022-10-31
- 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 Code Classifications
| Code | Device | Specialty | Class |
|---|
| GAD | Retractor | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840199544868 | Direct Marking | GS1 | 0 | |
| 10840199544865 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840199544868 | 00840199544868 | 840199544868 | 0840199544868 |
| 10840199544865 | 10840199544865 | | |
GMDN Terms
| Term | Definition |
|---|
| Self-retaining surgical retractor, reusable | A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in dry place at room temperature |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 007928633
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- 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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