AccessGUDID - DEVICE: Integra® PyroSphere® (10381780242499)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® PyroSphere®
Version or Model: BRH44530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRH-445-30
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780242499
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: Spherical Burr used to create an opening in the bone.

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?
36249	Orthopaedic bur, reusable	A 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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTT	BURR, ORTHOPEDIC

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size 30

Device Record Status

Public Device Record Key: 45aa18be-b59c-462c-ade1-35972c45b996
Public Version Date: January 25, 2023
Public Version Number: 4
DI Record Publish Date: September 05, 2017