AED
- Primary DI
- 00848657013307
- Brand
- AED
- Company
- NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Model
- 32-4085-TE
- Device description
- ELLIK ADAPTER
- Published
- 2017-11-28
- 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 |
|---|
| KQT | EVACUATOR, GASTRO-UROLOGY |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KQT | Evacuator, Gastro-Urology | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00848657013307 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00848657013307 | 00848657013307 | 848657013307 | 0848657013307 |
GMDN Terms
| Term | Definition |
|---|
| Rigid cystoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 839138955
- 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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|---|
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| 10724995183803 | BioVac | US Endoscopy | KQT | 2020-04-01 |
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| 00860002476148 | Intussusception Air Reduction Bulb & Gauge with Plastic Case | GRI MEDICAL PRODUCTS INC | KQT | 2019-12-18 |
| 00860002476155 | Occlusion Disc | GRI MEDICAL PRODUCTS INC | KQT | 2019-12-18 |
| 00860002476162 | Intussusception Pressure Relief Valve | GRI MEDICAL PRODUCTS INC | KQT | 2019-12-18 |
| 00841436104579 | CollectEVAC | CIVCO MEDICAL INSTRUMENTS CO., INC. | KQT | 2018-01-03 |
| 00841436108614 | Cook CollectEVAC | CIVCO MEDICAL INSTRUMENTS CO., INC. | KQT | 2018-01-03 |
| 00827002515499 | Cook CollectEVAC | CIVCO MEDICAL INSTRUMENTS CO., INC. | KQT | 2018-01-03 |
| 00848657016889 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | KQT | 2017-11-28 |
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| 00814334021156 | NA | Richard Wolf GmbH | KQT | 2016-09-30 |
| 08714729045069 | NA | BOSTON SCIENTIFIC CORPORATION | KQT | 2016-09-24 |
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