FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ITN Implant
DI: B487EXITN9245500
·
Model: EXITN924550
·
Exsomed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ITN Implant
- Primary DI
- B487EXITN9245500
- Version / Model
- EXITN924550
- Catalog Number
- EXITN924550
- Company Name
- Exsomed Corporation
- Labeler DUNS
- 116722111
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-06
- Public Version
- 4
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 759e4fd5-cd69-47a3-af81-c608fe572bb7
- Distribution End Date
- 2023-06-30
Device Description
ITN Implant is a stainless steel bone screw
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66497 | Stress-therapy vibroacoustic headband | An electrically-powered wearable device intended to apply vibroacoustic therapy (VAT) stimuli to the head to treat stress and sleep disorder symptoms (e.g., insomnia, migraine, anxiety) by inducing a state of brain relaxation. It is typically in the form of a headband to be positioned over the forehead and temporal areas of the head, and includes dedicated software for vibration frequency programming from a wirelessly connected smart device (not included). It is intended to be used in clinical and home settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B487EXITN9245500 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 50 | Millimeter | |
| Outer Diameter | 4.5 | Millimeter |