FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479269491
·
Model: 16-LC-LSO
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479269491
- Version / Model
- 16-LC-LSO
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-09
- Public Version
- 1
- Public Version Date
- 2024-09-17
- Public Version Status
- New
- Public Device Record Key
- d0d94f44-7692-4ef2-8896-475a389dd973
Device Description
LIGHT SOURCE, EAR CURETTE
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JYG | Curette, Ear | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65447 | ENT instrument light source | An electrically-powered, noninvasive device intended to be attached to the proximal end of an appropriate ear/nose/throat (ENT) instrument (e.g., curette or forceps) [not included] to produce light and facilitate visualization. It is designed for use with an instrument with light transmitting features; it is not intended for endoscopic use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00612479269491 | GS1 |