FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 20845854080730
·
Model: 57525424
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- NA
- Primary DI
- 20845854080730
- Version / Model
- 57525424
- Catalog Number
- 57525424
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- dc85ccb4-75c4-4254-8c6a-ca6351ddabf3
Device Description
Laparoscopy tube set SEO, 12 pieces
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
- 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 |
|---|---|---|---|---|
| GAZ | TUBING, NONINVASIVE | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46483 | Surgical plume evacuation system tube | A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30845854080737 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 20845854080730 | GS1 | ||||
| Unit of Use | 00845854080736 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 0 – 1 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -13 – 158 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY