Avalign
- Primary DI
- 00190776044305
- Brand
- Avalign
- Company
- AVALIGN TECHNOLOGIES, INC.
- Model
- VM101-4456
- Device description
- Measuring Rod,
- Published
- 2021-11-03
- 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 |
|---|
| JYZ | ROD, MEASURING EAR |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JYZ | Rod, Measuring Ear | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00190776044305 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00190776044305 | 00190776044305 | 190776044305 | 0190776044305 |
GMDN Terms
| Term | Definition |
|---|
| Nasal depth gauge, reusable | A manual instrument designed for introduction into and measurement of the nasal cavities and paranasal sinuses during diagnostic and/or surgical procedures. It typically consists of a hand-held, slender, rod-like metallic device with a fine blunt distal end; the device usually includes rings (e.g., 3, 4, 5 mm) with calibrated diameters at its distal end to perform the measurements. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 792528510
- Device count
- 1
- DM exempt
- false
- 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
- false
- Sterilization required before use
- true
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| 00190776044299 | Avalign | Avalign Technologies, Inc. | JYZ | 2023-09-28 |
| 00190776319571 | MILLENNIUM | Avalign Technologies, Inc. | JYZ | 2023-09-28 |
| 00190776319588 | MILLENNIUM | Avalign Technologies, Inc. | JYZ | 2023-09-28 |
| G043655090 | BEAR | Bear-Ent, LLC | JYZ | 2023-08-08 |
| G043655100 | BEAR | Bear-Ent, LLC | JYZ | 2023-08-08 |
| 00190776369729 | Millennium | AVALIGN TECHNOLOGIES, INC. | JYZ | 2023-02-22 |
| 54026704805193 | PILLING | TELEFLEX INCORPORATED | JYZ | 2022-12-08 |
| 54026704805186 | PILLING | TELEFLEX INCORPORATED | JYZ | 2022-12-08 |
| 54026704805209 | PILLING | TELEFLEX INCORPORATED | JYZ | 2022-12-08 |
| 14026704805218 | PILLING | TELEFLEX INCORPORATED | JYZ | 2022-12-08 |
| 00842331174711 | Novo Surgical Inc. | NOVO SURGICAL, INC. | JYZ | 2022-11-14 |
| 00842331179525 | Novo Surgical Inc. | NOVO SURGICAL, INC. | JYZ | 2022-11-14 |
| 00840343700584 | Gen2 | SURGIX MEDICAL LLC | JYZ | 2022-10-18 |
| G277G2E9009610 | Gen2 | SURGIX MEDICAL LLC | JYZ | 2022-09-23 |
| 04250676726872 | Caversaccio Tympano Sizer | Spiggle & Theis Medizintechnik GmbH | JYZ | 2022-09-12 |
| 00190776044282 | Avalign | AVALIGN TECHNOLOGIES, INC. | JYZ | 2021-11-03 |
| B351B655100 | BEAR | Mytamed, Inc. | JYZ | 2021-11-01 |
| B351B655110 | BEAR | Mytamed, Inc. | JYZ | 2021-11-01 |
| B351B655120 | BEAR | Mytamed, Inc. | JYZ | 2021-11-01 |
| B351B655130 | BEAR | Mytamed, Inc. | JYZ | 2021-11-01 |
| 00190660001926 | Ambler Surgical | AMBLER SURGICAL CORP. | JYZ | 2021-01-04 |