FDA UDI
Not in Commercial Distribution
🇺🇸 United States
First+Aid
DI: 00048341007012
·
Model: B GRDL 0300 R03606 FAB [was B GRDL 0300 R03606 FBB]
·
U.S. COTTON, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
300
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Basic Information
- Brand Name
- First+Aid
- Primary DI
- 00048341007012
- Version / Model
- B GRDL 0300 R03606 FAB [was B GRDL 0300 R03606 FBB]
- Catalog Number
- B GRDL 0300 R03606 FAB
- Company Name
- U.S. COTTON, LLC
- Labeler DUNS
- 932938897
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2020-02-28
- Public Version
- 5
- Public Version Date
- 2024-12-24
- Public Version Status
- Update
- Public Device Record Key
- 3dcd82b0-2b28-4124-9270-59f16c409b0c
- Distribution End Date
- 2024-02-12
Device Description
Cotton Balls (300ct Large Size)
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
- 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 |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63281 | Cotton wool ball | A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10048341007019 | GS1 | Case | 36 | Not in Commercial Distribution | 2024-02-12 |
| Primary | 00048341007012 | GS1 | ||||
| Unit of Use | 10048341800023 | GS1 |
Customer Contacts
- Phone
- 1-800-321-1029
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store indoors under normal ambient conditions in sealed package