FDA UDI
In Commercial Distribution
🇺🇸 United States
Calcusplit
DI: 04048551086643
·
Model: 27632534
·
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
- Calcusplit
- Primary DI
- 04048551086643
- Version / Model
- 27632534
- Catalog Number
- 27632534
- 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
- 3feaa9db-9d0c-4704-93ee-87f3e43ad6db
Device Description
CALCUSPLIT® Lithotripsy Wire Probe
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 |
|---|---|---|---|---|
| FFK | Lithotriptor, electro-hydraulic | Gastroenterology, Urology | 876.4480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65261 | Pneumatic lithotripsy system probe, urinary | A slender, metal, rod-like device intended to be attached to a pneumatic lithotripsy system handpiece to deliver pneumatically-created ballistic shock waves from an appropriate energy source to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation in situ. It is introduced endoscopically through a natural body orifice or surgically-made opening; it is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551086643 | GS1 |
Customer Contacts
- Phone
- +14242188201
- [email protected]