FDA UDI
In Commercial Distribution
🇺🇸 United States
MICTEC ASPIRATION CANNULA
DI: 00192896008984
·
Model: 26941-42
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MICTEC ASPIRATION CANNULA
- Primary DI
- 00192896008984
- Version / Model
- 26941-42
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 2
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- afc6b7ea-882d-4121-9681-c1b2b311c6ac
Device Description
MICTEC ASPIRATION CANNULA WITH NEEDLE GAUGE 18
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
- No
- 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", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37462 | Body aspiration needle, reusable | A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B09926941420 | HIBCC | ||||
| Primary | 00192896008984 | GS1 |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 360 | Millimeter | |
| Device Size Text, specify | 5mm Tip |