N/A
- Primary DI
- 00763000035259
- Brand
- N/A
- Company
- MEDTRONIC XOMED, INC.
- Model
- 1133285
- Device description
- PROSTHESIS 1133285 LIPPY CUP PSTN .4X4.5
- Published
- 2021-06-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| ETA | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ETA | Replacement, Ossicular Prosthesis, Total | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00763000035259 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00763000035259 | 00763000035259 | 763000035259 | 0763000035259 |
GMDN Terms
| Term | Definition |
|---|
| Ossicular prosthesis, partial | A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Length | 4.5 | Millimeter |
Regulatory Flags
- DUNS number
- 835465063
- 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
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00844505014663 | OFFSET TITANIUM WILDCAT ALTO | Grace Medical, Inc. | ETA | 2025-07-17 |
| 00763000913489 | N/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913496 | Bojrab | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913502 | Causse/Polycel | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913519 | Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913526 | Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913533 | Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913540 | Causse/Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913557 | Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913564 | Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913571 | Causse/Vincent | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913595 | Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913601 | Flex H/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913625 | N/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913632 | N/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913649 | N/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913656 | N/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913663 | Silverstein | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913717 | Sheehy/Polycel | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913724 | Sheehy/Polycel | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913731 | N/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000913762 | N/A | MEDTRONIC XOMED, INC. | ETA | 2025-06-23 |
| 00763000033385 | HA/C Polycel® Brackmann Total | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
| 00763000034832 | Sheehy HA/C Polycel® P.O.P. | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
| 00763000034849 | Sheehy HA/C Polycel® T.O.P. | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
| 00763000036591 | Big Easy® Piston | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
| 00763000036607 | Big Easy® Piston | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
| 00763000036614 | Big Easy® Piston | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
| 00763000036621 | Big Easy® Piston | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
| 00763000036638 | Big Easy® Piston | MEDTRONIC XOMED, INC. | ETA | 2024-05-12 |
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