FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kendall
DI: 20192253052876
·
Model: 41550
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- Kendall
- Primary DI
- 20192253052876
- Version / Model
- 41550
- Catalog Number
- 41550
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2024-07-29
- Public Version
- 4
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- d7bc958a-7e09-4f8b-8813-52b741bb0d2f
- Distribution End Date
- 2025-06-30
Device Description
SPONGE STICK WITH PVP-I
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEC | BRUSH, SCRUB, OPERATING-ROOM | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47077 | Surgical scrub brush, single-use | A hand-held device used by hospital staff to scrub their hands, fingers, and forearms prior to surgery or other intervention where a high degree of personal hygiene is required; it may also be used to mechanically clean the intact skin or superficial wounds of a patient. This device typically has a synthetic sponge surface and a soft bristle surface; it may also include a separate nail cleaner and/or a disinfecting substance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253052877 | GS1 | CASE | 10 | Not in Commercial Distribution | 2025-06-30 |
| Primary | 20192253052876 | GS1 | ||||
| Unit of Use | 10192253052879 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius