AccessGUDID - DEVICE: PIRANHA (04055207049105)

GUDID

Device Identifier (DI) Information

Brand Name: PIRANHA
Version or Model: 49700113
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 49700113
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207049105
Issuing Agency: GS1
Commercial Distribution End Date: June 29, 2017
Device Count: 3
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: ROTATIONS-MORCELLATOR Ø 4.8MM WL 335MM for MORCESCOPE, for morcellation following laser prostate enucleation, sterile

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):	No
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?
46729	Tissue morcellation system	An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FJK	SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 335 Millimeter
Outer Diameter: 4.8 Millimeter

Device Record Status

Public Device Record Key: 81182208-b99e-41ca-9efe-167f92e75283
Public Version Date: December 24, 2018
Public Version Number: 4
DI Record Publish Date: June 28, 2017