FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551079386
·
Model: 27074B
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048551079386
- Version / Model
- 27074B
- Catalog Number
- 27074B
- 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
- 5
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- 40f93536-42e2-4758-964b-81ec3b4cb0cd
Device Description
Stone Crushing Forceps, sgl. action jaws
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 |
|---|---|---|---|---|
| OCZ | Endoscopic grasping/cutting instrument, non-powered | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12379 | Lithotrite | A hand-held manual surgical instrument designed for the mechanical crushing of renal stones (calculi) in the urinary tract and/or bladder. It is typically designed with a sturdy pair of jaws at the distal end that are placed over and crush the stone when the operator applies pressure to the handles at the proximal end; the jaws close, grasp and crush the stone. Some types may employ a screw spindle which the operator can rotate to augment the crushing force. The instrument may be used endoscopically and may include a port for irrigation to provide a clear visual field. This device reflects old technology. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551079386 | GS1 |
Customer Contacts
- Phone
- +14242188201
- [email protected]