FDA UDI
In Commercial Distribution
🇺🇸 United States
MPM CoolMagic
DI: 00366977206334
·
Model: 3
·
Mpm Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MPM CoolMagic
- Primary DI
- 00366977206334
- Version / Model
- 3
- Catalog Number
- MP00206
- Company Name
- Mpm Medical, LLC
- Labeler DUNS
- 081241522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- adbe388e-dc19-4afd-9cf4-6b54935cfe43
Device Description
MPM CoolMagic Clear Hydogel Sheet Wound Drsg 3.75X3.75. Package configuration: 10 Dressings. Per sbs; 3 sbs per case.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59102 | Genital inflammation/infection hydrogel dressing | A gel intended to be applied to the skin or mucosa to treat inflammation/infection of the external genitalia (e.g., vulvitis and balanitis) through hydration and infection control properties (e.g., microbial binding, persistent barrier to help prevent secondary infection). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00366977206334 | GS1 |
Customer Contacts
- Phone
- 8002325512
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973693 | 000 |