FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10653405005780
·
Model: 60-3950-031
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- NA
- Primary DI
- 10653405005780
- Version / Model
- 60-3950-031
- Catalog Number
- 60-3950-031
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 5
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- e6af8488-36b7-4fad-b773-f5c3982d4a40
Device Description
Reposable Bladed Mini Trocar
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KQM | CAMERA, SURGICAL AND ACCESSORIES | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20653405005787 | GS1 | BOX | 20 | In Commercial Distribution | |
| Primary | 10653405005780 | GS1 | ||||
| Unit of Use | 00653405005783 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Inch | |
| Outer Diameter | 12.7 | Centimeter | |
| Length | 96 | Inch | |
| Length | 244 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY