FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 20888551044308
·
Model: AUT179094F-3
·
STERILMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 20888551044308
- Version / Model
- AUT179094F-3
- Catalog Number
- AUT179094F-3
- Company Name
- STERILMED, INC.
- Labeler DUNS
- 175899459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 4e8f4d13-7cda-40b3-9fe3-e68c3b248534
Device Description
Versaport V2 Trocar with Fixation Cannula 3/bx
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NLM | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61814 | Laparoscopic trocar blade, reprocessed | A rigid surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20888551044308 | GS1 |
Customer Contacts
- Phone
- +1(888)541-0078
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012578 | 000 |