FDA UDI
In Commercial Distribution
🇺🇸 United States
Panty Liner
DI: 00616784133522
·
Model: 1335
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Panty Liner
- Primary DI
- 00616784133522
- Version / Model
- 1335
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-09-01
- Public Version
- 1
- Public Version Date
- 2021-09-09
- Public Version Status
- New
- Public Device Record Key
- dee59410-2818-43f5-a762-bc236ecf8fa5
Device Description
Panty Liners, Sq. End. w/ Adhesive Tab 4"x11" (21g), Medium
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | 876.5920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35817 | Incontinence pants liner | A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784133539 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00616784133522 | GS1 | ||||
| Unit of Use | 00616784133515 | GS1 |