FDA UDI
Not in Commercial Distribution
🇺🇸 United States
2XChromosome
DI: 00850022610035
·
Model: (2X)200920SP
·
Global Health Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- 2XChromosome
- Primary DI
- 00850022610035
- Version / Model
- (2X)200920SP
- Catalog Number
- PBOSN003
- Company Name
- Global Health Solutions LLC
- Labeler DUNS
- 117588619
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 2
- Public Version Date
- 2022-08-01
- Public Version Status
- Update
- Public Device Record Key
- 560af7ed-a4f4-47cd-9ade-622cf15b8ab6
- Distribution End Date
- 2021-12-31
Device Description
Super Maxi Pad With Wings; individually wrapped, organic cotton top sheet
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
- 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 |
|---|---|---|---|---|
| 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 | 10850022610032 | GS1 | 48 | Not in Commercial Distribution | 2021-12-31 | |
| Primary | 00850022610035 | GS1 | ||||
| Unit of Use | 00850022610103 | GS1 |