FDA UDI
In Commercial Distribution
🇺🇸 United States
TOPCARE
DI: 00036800115811
·
Model: 10003433
·
TOPCO ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
22
Basic Information
- Brand Name
- TOPCARE
- Primary DI
- 00036800115811
- Version / Model
- 10003433
- Company Name
- TOPCO ASSOCIATES, LLC
- Labeler DUNS
- 072943876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 22
- Record Status
- Published
- Publish Date
- 2020-08-03
- Public Version
- 1
- Public Version Date
- 2020-08-11
- Public Version Status
- New
- Public Device Record Key
- 7aa53d52-0e14-4983-861b-d99431dce4a2
Device Description
MINI SHIELD UNSCENTED 22CNT
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | Obstetrics/Gynecology | 884.5435 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40545 | Menstrual pad, unscented | A non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10036800115818 | GS1 | Shipping Case | 18 | In Commercial Distribution | |
| Primary | 00036800115811 | GS1 | ||||
| Unit of Use | 00003680011588 | GS1 |