FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479225039
·
Model: 16-8919
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479225039
- Version / Model
- 16-8919
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-24
- Public Version
- 1
- Public Version Date
- 2019-05-02
- Public Version Status
- New
- Public Device Record Key
- 46e6c4b6-bdef-4361-a2dc-ae5354879ec9
Device Description
Lubricating Jelly STERILE | WATER SOLUBLE | GREASELESS | UNSCENTED 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
- 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 |
|---|---|---|---|---|
| KMJ | Lubricant, Patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60795 | Multi-purpose surgical instrument lubricant | A sterile substance intended to be applied to a sterile surgical instrument prior to use for device mechanical and patient lubrication purposes (e.g., to facilitate moving parts of device, and to facilitate movement between instrument and patient); it is not dedicated to a specific type of surgical instrument. It includes plant-derived materials (e.g., glycerin) and may also be intended for non-surgical applications (e.g., entry of a device into a body orifice). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479225053 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 00612479225046 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00612479225039 | GS1 |