FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Applicator Cover
DI: 20868924000018
·
Model: PVTC30
·
Regenesis Biomedical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Disposable Applicator Cover
- Primary DI
- 20868924000018
- Version / Model
- PVTC30
- Company Name
- Regenesis Biomedical, Inc.
- Labeler DUNS
- 018207519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2fb830a0-e266-4999-a113-48a2a984cf5b
Device Description
Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers.
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
- 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 |
|---|---|---|---|---|
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | Physical Medicine | 890.5290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62236 | Electromagnetic stimulation system application pad | A non-sterile pad intended to be placed on the skin of a patient, or on the parent device, to provide a contact surface for an electromagnetic stimulation applicator, and a barrier to cross-contamination between the applicator and the patient, during treatment. It is typically made of polyethylene terephthalate (polyester) film and may contain a radio-frequency identification (RFID) tag which helps prevent reuse of the pad. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20868924000018 | GS1 | ||||
| Unit of Use | 00868924000014 | GS1 |
Customer Contacts
- Phone
- 480-297-5800
- [email protected]