FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaMed
DI: 00810113682457
·
Model: Lidocaine 4% pain releiving gel patch / 6 patches
·
MANAMED INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- ManaMed
- Primary DI
- 00810113682457
- Version / Model
- Lidocaine 4% pain releiving gel patch / 6 patches
- Catalog Number
- LIDOOTC6
- Company Name
- MANAMED INC
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-07-01
- Public Version
- 1
- Public Version Date
- 2022-07-11
- Public Version Status
- New
- Public Device Record Key
- ce941007-8874-4a9c-afbc-d8191fad90a7
Device Description
ManaMed Lidocaine patches have 4% lidocaine providing odorless pain-relieving ointment on a breathable adhesive patch. Same active ingredients as common national brands. No irritation, no burning, targets aggravated nerves, fast acting.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OMW | Adhesive Backed Thermal Skin Patches | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35955 | Transdermal medication patch | A medication-impregnated device designed as a skin patch that is fixed to the skin, typically with a pressure-sensitive adhesive, for dermal absorption of the medication (e.g., pain relief local anaesthetic agent). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113682457 | GS1 | ||||
| Unit of Use | 00810113680903 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]