FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551051634
·
Model: 11574A
·
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
- 04048551051634
- Version / Model
- 11574A
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fdba45dc-7157-43dd-8e40-05a2e1dcd9f7
Device Description
Mini Straight Forward Telescope 0°,1.6mm
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
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 |
|---|---|---|---|---|
| 58936 | Sialendoscope | An endoscope with a slender semiflexible inserted portion intended for the visual examination and treatment of the salivary ducts. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in combination with special instruments (e.g., forceps, laser probes, stone extractors) to locate and extract/treat a salivary stone (sialolithiasis) and/or a stricture (sialostenosis) in the submandibular, parotid, and/or sublingual salivary duct. This is a reusable device intended to be sterilized before use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551051634 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012527 | 000 |