FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MICTEC SUCTION TUBE
DI: B09920943140
·
Model: 20943-14
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MICTEC SUCTION TUBE
- Primary DI
- B09920943140
- Version / Model
- 20943-14
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 7
- Public Version Date
- 2018-09-24
- Public Version Status
- Update
- Public Device Record Key
- 8334163a-abf2-42fd-a108-35ba495afb4d
- Distribution End Date
- 2018-09-23
Device Description
MICTEC SUCTION TUBE WITH BASKET, BIG CENTRAL OPENING CURVED
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 |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45254 | Suction cannula, reusable | A rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B09920943140 | HIBCC |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4.5mm Diameter | ||
| Length | 300 | Millimeter | |
| Device Size Text, specify | 30° Jaw |