FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Devon
DI: 20192253051978
·
Model: 31140125
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
Basic Information
- Brand Name
- Devon
- Primary DI
- 20192253051978
- Version / Model
- 31140125
- Catalog Number
- 31140125
- 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
- 2025-04-14
- Public Version
- 3
- Public Version Date
- 2025-12-31
- Public Version Status
- Update
- Public Device Record Key
- ee7ed63a-34a4-4286-8fd7-cbfa2b376141
- Distribution End Date
- 2025-12-31
Device Description
Devon Light Handle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| FSY | Light, surgical, ceiling mounted | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44977 | Medical equipment handle cover, single-use | A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30192253051975 | GS1 | Carton | 14 | Not in Commercial Distribution | 2025-12-31 |
| Primary | 20192253051978 | GS1 | ||||
| Package | 50192253051979 | GS1 | CASE | 4 | Not in Commercial Distribution | 2025-12-31 |
| Unit of Use | 10192253051971 | GS1 |