Sklar
- Primary DI
- 30649111028575
- Brand
- Sklar
- Company
- SKLAR CORPORATION
- Model
- 78-2821
- Device description
- BRUSH TRAC TUBE SM 1/2 IN D PK/6
- Published
- 2019-07-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| EPE | BRUSH, CLEANING, TRACHEAL TUBE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EPE | Brush, Cleaning, Tracheal Tube | Anesthesiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 30649111028575 | Primary | GS1 | 0 | |
| 06491110285755 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 30649111028575 | 30649111028575 | |
| 06491110285755 | 06491110285755 | 6491110285755 |
GMDN Terms
| Term | Definition |
|---|
| Surgical instrument/endoscope cleaning brush/tool, single-use | A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device. |
Regulatory Flags
- DUNS number
- 006966006
- Device count
- 6
- 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
- true
- Sterilization required before use
- false
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|---|
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| 30649111029107 | Sklar | SKLAR CORPORATION | EPE | 2019-07-17 |
| 50649111341869 | Sklar | SKLAR CORPORATION | EPE | 2019-07-17 |
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