AincA®
- Primary DI
- B00500458M0
- Brand
- AincA®
- Company
- ANESTHESIA ASSOCIATES, INC.
- Model
- 00-458-M
- Catalog number
- 00-458-M
- Device description
- Brush, Cleaning, Tracheal Tube, 12.7" x 3/8" (9.5mm), Medium
- Published
- 2021-03-31
- 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 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 |
|---|
| B00500458M0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Surgical instrument/endoscope cleaning brush/tool, reusable | 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 reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 002065670
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- 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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| M36834130 | Grafco | GF HEALTH PRODUCTS, INC. | EPE | 2021-05-10 |
| B00500458L0 | AincA® | ANESTHESIA ASSOCIATES, INC. | EPE | 2021-03-31 |
| B00500458S0 | AincA® | ANESTHESIA ASSOCIATES, INC. | EPE | 2021-03-31 |
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| 50649111341869 | Sklar | SKLAR CORPORATION | EPE | 2019-07-17 |
| 24026704265163 | KMEDIC | TELEFLEX INCORPORATED | EPE | 2018-09-15 |
| 24026704265170 | KMEDIC | TELEFLEX INCORPORATED | EPE | 2018-09-15 |