AccessGUDID - DEVICE: TIPCONTROL (04055207053805)

GUDID

Device Identifier (DI) Information

Brand Name: TIPCONTROL
Version or Model: 499751005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 499751005
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207053805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: NUCLEUS RESECTOR ARTICULATING Ø 5.5MM for soft tissue extraction, in endoscopic spine surgery, for use with motor handpieces M5/0 and M5/3, WL 350mm, PU= 3 pcs, sterile, for single use

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:	Yes
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?
45553	Orthopaedic bur, single-use	A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: e5198c53-eb39-4764-bf8c-b0725593f86c
Public Version Date: November 21, 2024
Public Version Number: 3
DI Record Publish Date: February 17, 2022