AccessGUDID - DEVICE: Calcusplit (04048551086643)

GUDID

Device Identifier (DI) Information

Brand Name: Calcusplit
Version or Model: 27632534
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 27632534
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551086643
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: CALCUSPLIT® Lithotripsy Wire Probe

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFK	Lithotriptor, electro-hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3feaa9db-9d0c-4704-93ee-87f3e43ad6db
Public Version Date: October 21, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +14242188201
Email: regulatory@karlstorz.com

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