FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479196827
·
Model: 22-9999-S
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479196827
- Version / Model
- 22-9999-S
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-05
- Public Version
- 2
- Public Version Date
- 2018-11-22
- Public Version Status
- Update
- Public Device Record Key
- 8fb0057c-ed62-4224-8c31-c6849ceda7f6
Device Description
McKesson Tongue Depressor Junior 5-1/2 Inch Wood 15.9 mm Wide Blade
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | 880.6230 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42461 | Tongue depressor, examination, single-use | A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479196841 | GS1 | Case | 10 | In Commercial Distribution | |
| Package | 00612479196834 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00612479196827 | GS1 |