FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551082485
·
Model: 27290K
·
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
- 04048551082485
- Version / Model
- 27290K
- 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
- dda555eb-31bf-4853-b6a6-8bbd07a5feb6
Device Description
Forceps
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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGA | Kit, nephroscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15800 | Dissection forceps | A surgical instrument used to facilitate grasping, manipulation, compression or joining of tissue during dissection and/or autopsy. It typically has two main designs: 1) a self-retaining, scissors-like design with ring handles with the working end having a variety of blade designs, e.g., straight, angled, or curved with parallel grooves or serrations to provide grip; and 2) tweezers-like design (may be a micro/fine instrument) with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes and may have carbide inserts at the working end. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551082485 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K940594 | 000 |