FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmersiveTouch
DI: B940IVZBKIT0
·
Model: ImmersiveTouch4
·
IMMERSIVETOUCH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ImmersiveTouch
- Primary DI
- B940IVZBKIT0
- Version / Model
- ImmersiveTouch4
- Company Name
- IMMERSIVETOUCH, INC.
- Labeler DUNS
- 801390100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-07
- Public Version
- 2
- Public Version Date
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- 3bd3ff3c-1303-403c-b0f0-bdb785be078a
Device Description
ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38453 | Portable computer | A portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard and/or touchscreen integrated into one unit in the form of a laptop, tablet, palmtop or other hand-held (including smartphone) device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B940IVZBKIT0 | HIBCC |
Customer Contacts
- Phone
- 7738405227
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140860 | 000 |