FDA UDI
In Commercial Distribution
🇺🇸 United States
FLEXIBLE TROCAR SLEEVE
DI: 00192896000131
·
Model: 15-16100-75
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FLEXIBLE TROCAR SLEEVE
- Primary DI
- 00192896000131
- Version / Model
- 15-16100-75
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-20
- Public Version
- 2
- Public Version Date
- 2018-12-31
- Public Version Status
- Update
- Public Device Record Key
- 031ca0b2-b519-42d2-ad99-ff94d63bb994
Device Description
FLEXIBLE TROCAR SLEEVE PACKAGE OF 12
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 |
|---|---|---|---|---|
| 62452 | Laparoscopic multi-instrument access port, reusable | A multi-lumen sleeve assembly intended to retract a small abdominal incision to allow multiple laparoscopic instruments to access the abdominal cavity simultaneously through a single abdominal incision, during minimally-invasive laparoscopic surgery. It will include a valve component for each lumen that maintains the established pneumoperitoneum; the trocar used to create the abdominal incision might be included; it may include attached external instrument holding arms. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B0991516100755 | HIBCC | ||||
| Primary | 00192896000131 | GS1 |
Customer Contacts
- Phone
- 8008217496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 7 | Millimeter | |
| Length | 70 | Millimeter |