FDA UDI
In Commercial Distribution
🇺🇸 United States
PERFORMA
DI: 10885914070663
·
Model: 565710
·
Performance Health Supply, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- PERFORMA
- Primary DI
- 10885914070663
- Version / Model
- 565710
- Catalog Number
- 565710
- Company Name
- Performance Health Supply, LLC
- Labeler DUNS
- 966806150
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 6
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 81455b29-df99-4476-bb7f-351316afce91
Device Description
PERFORMA FOAM 2" ROUND - 4/PK
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885914070663 | GS1 | ||||
| Unit of Use | 00885914070666 | GS1 |
Customer Contacts
- Phone
- 8003235547
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 3.14 | Square inch |