FDA UDI
In Commercial Distribution
🇺🇸 United States
Quinelato
DI: 07898506816484
·
Model: QX.385.19
·
Schobell Industrial Ltda
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quinelato
- Primary DI
- 07898506816484
- Version / Model
- QX.385.19
- Catalog Number
- QX.385.19
- Company Name
- Schobell Industrial Ltda
- Labeler DUNS
- 899060826
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-09
- Public Version
- 1
- Public Version Date
- 2023-01-17
- Public Version Status
- New
- Public Device Record Key
- 4650cf2c-bb82-4d15-a0fc-013b26fb6074
Device Description
Bruenings tongue depressor
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
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63659 | Tongue depressor, examination, reusable | A hand-held device intended to be 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 it less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898506816484 | GS1 |