FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rite Aid
DI: 00011822311069
·
Model: L FZUSS 0040 R02401 RT
·
U.S. COTTON, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Rite Aid
- Primary DI
- 00011822311069
- Version / Model
- L FZUSS 0040 R02401 RT
- Company Name
- U.S. COTTON, LLC
- Labeler DUNS
- 932938897
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-28
- Public Version
- 2
- Public Version Date
- 2022-01-04
- Public Version Status
- Update
- Public Device Record Key
- 9ec63698-f495-497d-8cce-ff2983a4b922
- Distribution End Date
- 2022-01-03
Device Description
Sterile Cotton Roll (4 oz)
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
- Yes
- 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 |
|---|---|---|---|---|
| 58233 | Cotton wool roll, sterile | A device designed as an absorbent, sterile mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector; it is not in the form of a bandage or dedicated dressing. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10011822311066 | GS1 | Case | 24 | Not in Commercial Distribution | 2022-01-03 |
| Primary | 00011822311069 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store indoors under normal ambient conditions in sealed package