FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048438001004
·
Model: 031129-10
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048438001004
- Version / Model
- 031129-10
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 20695881-75b8-4ffa-885b-c8ebb6221f3a
Device Description
Tubing Set, CLEARVISION (irrigation)
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
- 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 |
|---|---|---|---|---|
| EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10217 | Surgical suction system | An assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048438001004 | GS1 | ||||
| Unit of Use | 04048438000991 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020599 | 000 |