FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00763000035112
·
Model: 1133005
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00763000035112
- Version / Model
- 1133005
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-17
- Public Version
- 1
- Public Version Date
- 2021-06-25
- Public Version Status
- New
- Public Device Record Key
- 6d91a1dd-96fd-494a-8d7d-8da034446e2e
Device Description
PROSTHESIS 1133005 CUP PISTON .4X4.0 SST
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETA | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL | Ear, Nose, Throat | 874.3495 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35690 | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000035112 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Well Diameter = 0.9 MM | ||
| Length | 4.0 | Millimeter | |
| Device Size Text, specify | Shaft Diameter = 0.4 MM |