FDA UDI
In Commercial Distribution
🇺🇸 United States
Devon
DI: 30884527011685
·
Model: 31140117
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
3
Basic Information
- Brand Name
- Devon
- Primary DI
- 30884527011685
- Version / Model
- 31140117
- Catalog Number
- 31140117
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- 8cd2a631-aab1-47af-9bf4-18b78cdd0eb3
Device Description
Light Handle
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
- 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 |
|---|---|---|---|---|
| 17977 | Medical equipment handle cover, single-use, non-sterile | A non-sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., examination/treatment light) to provide a hygienic barrier between the handle and the hand of a healthcare professional. 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 | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884527011681 | GS1 | CASE | 84 | In Commercial Distribution | |
| Primary | 30884527011685 | GS1 | ||||
| Package | 20884527011688 | GS1 | PACK_OR_INNER_PACK | 21 | In Commercial Distribution | |
| Unit of Use | 40884527011682 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry;AVOID DIRECT SUNLIGHT