FDA UDI
In Commercial Distribution
🇺🇸 United States
REAL y-Series
DI: 00815948029477
·
Model: RLY2EVAL-A
·
PENUMBRA, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- REAL y-Series
- Primary DI
- 00815948029477
- Version / Model
- RLY2EVAL-A
- Company Name
- PENUMBRA, INC.
- Labeler DUNS
- 191077671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-16
- Public Version
- 1
- Public Version Date
- 2024-04-24
- Public Version Status
- New
- Public Device Record Key
- c276678b-ebc2-4b35-bcb5-3535db0eae9f
Device Description
REAL y-Series 2 Eval
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60925 | Virtual-display rehabilitation system, non-supportive, clinical | An assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface. | No | Active |
| 65392 | Mental health/function therapeutic software, virtual reality | A virtual reality software program intended to be used with an off-the-shelf device in conjunction with a virtual reality headset (not included) to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., attention/concentration, reading ability) by providing a patient with an interactive, immersive game; it is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient at home, school, and in clinical settings in conjunction with clinician consultation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815948029477 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183296 | 000 |