FDA UDI
In Commercial Distribution
🇺🇸 United States
Madsen
DI: 05713315009013
·
Model: 1012 OTOflex Cavity set
·
Gn Otometrics A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Madsen
- Primary DI
- 05713315009013
- Version / Model
- 1012 OTOflex Cavity set
- Catalog Number
- 8-67-41300
- Company Name
- Gn Otometrics A/S
- Labeler DUNS
- 306633756
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-11
- Public Version
- 1
- Public Version Date
- 2021-08-19
- Public Version Status
- New
- Public Device Record Key
- d15987c0-c800-4b74-9688-f6d278fa38f1
Device Description
Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETY | Tester, Auditory Impedance | Ear, Nose, Throat | 874.1090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36717 | Impedance audiometer | An electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713315009013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033645 | 000 |