FDA UDI
In Commercial Distribution
🇺🇸 United States
Quinelato
DI: 07898506815166
·
Model: QS.591.28
·
Schobell Industrial Ltda
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quinelato
- Primary DI
- 07898506815166
- Version / Model
- QS.591.28
- Catalog Number
- QS.591.28
- Company Name
- Schobell Industrial Ltda
- Labeler DUNS
- 899060826
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 1
- Public Version Date
- 2023-07-13
- Public Version Status
- New
- Public Device Record Key
- 8f719fb7-ec2b-4bbc-9b9e-995d607e82b8
Device Description
Collin Uterine Probe graduated 28cm
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 |
|---|---|---|---|---|
| HCY | Curette, Uterine | Obstetrics/Gynecology | 884.4530 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63993 | Uterine probe | A slender, rod-like, hand-held manual surgical instrument intended to be used to explore the uterus during a surgical procedure. It is typically intended to be used as a component of a uterine manipulator and as such may have a suction channel for applying a vacuum to fixate the manipulator assembly to the uterus. It is made of metal with an atraumatic tip; it may include graduated markings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898506815166 | GS1 |