FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Optical Separator® System
DI: 00607915113995
·
Model: C0115
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Optical Separator® System
- Primary DI
- 00607915113995
- Version / Model
- C0115
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-25
- Public Version
- 4
- Public Version Date
- 2020-01-09
- Public Version Status
- Update
- Public Device Record Key
- df165a11-d2d3-43a1-91ee-4278b09786d4
- Distribution End Date
- 2018-11-06
Device Description
Optical Separator Trocar
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 42412 | Laparoscopic access cannula, single-use | A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607915113992 | GS1 | 6 | Not in Commercial Distribution | 2018-11-06 | |
| Primary | 00607915113995 | GS1 |
Customer Contacts
- Phone
- 1.949.713.8300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter | |
| Lumen/Inner Diameter | 11 | Millimeter |