AccessGUDID - DEVICE: VERTEBRIS (04055207063071)

GUDID

Device Identifier (DI) Information

Brand Name: VERTEBRIS
Version or Model: 88660091
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88660091
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207063071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: BONE NEEDLE SHARP OD 2MM TL239,5MM for use with handle attachement 8866.601, graduated

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?
36167	Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBH	Accessories, arthroscopic

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2 Millimeter
Length: 239.5 Millimeter

Device Record Status

Public Device Record Key: 605eecd9-b5a5-4d0b-8e3d-d64a1318c7c1
Public Version Date: November 21, 2024
Public Version Number: 3
DI Record Publish Date: August 07, 2024