FDA UDI
In Commercial Distribution
🇺🇸 United States
PlayMakar
DI: 00856675008274
·
Model: PRO-504
·
PLAYMAKAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PlayMakar
- Primary DI
- 00856675008274
- Version / Model
- PRO-504
- Catalog Number
- PRO-504
- Company Name
- PLAYMAKAR INC.
- Labeler DUNS
- 081212270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-22
- Public Version
- 2
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 5b2331c6-8b36-42be-bd19-0d974a071e5a
Device Description
PLAYMAKAR SPORT SNAP ELECTRODES REFILL KIT
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
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20856675008278 | GS1 | Master Case | 4 | In Commercial Distribution | |
| Package | 10856675008271 | GS1 | Inner Carton | 10 | In Commercial Distribution | |
| Primary | 00856675008274 | GS1 |
Customer Contacts
- Phone
- 8337529625
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082065 | 000 |