FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551225387
·
Model: 10970A
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048551225387
- Version / Model
- 10970A
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- a03c2e91-5b8f-49a6-a83e-947bdfee9013
Device Description
Mediastinoscope, 13 cm
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Liquid Chemical", "Moist Heat or Steam Sterilization", "Hydrogen Peroxide", "Ethylene Oxide", "Peracetic Acid"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EWY | MEDIASTINOSCOPE, SURGICAL | Ear, Nose, Throat | 874.4720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35187 | Rigid optical mediastinoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551225387 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K954910 | 000 |