FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CONMED
DI: 00412786063115
·
Model: SB534
·
UNIMAX MEDICAL SYSTEMS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CONMED
- Primary DI
- 00412786063115
- Version / Model
- SB534
- Company Name
- UNIMAX MEDICAL SYSTEMS INC.
- Labeler DUNS
- 658122465
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-22
- Public Version
- 3
- Public Version Date
- 2020-01-09
- Public Version Status
- Update
- Public Device Record Key
- dbc24819-9ff4-4495-9396-7dc818eaaf2c
- Distribution End Date
- 2019-10-31
Device Description
Endo pouch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 | 20412786063119 | GS1 | Carton | 10 | Not in Commercial Distribution | 2019-10-31 |
| Package | 10412786063112 | GS1 | Box | 10 | Not in Commercial Distribution | 2019-10-31 |
| Primary | 00412786063115 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 3 | Inch | |
| Height | 6 | Inch |