AccessGUDID - DEVICE: BUDDE® (10381780355281)

GUDID

Device Identifier (DI) Information

Brand Name: BUDDE®
Version or Model: S438A1188
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA LIFESCIENCES CORPORATION

Primary DI Number: 10381780355281
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 963856096 *Terms of Use

Device Description: BUDDE® Halo 12” Support Rod (5/16”)

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?
62772	Neurosurgical retraction system, brain	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of brain tissue during neurosurgery. It includes a mounting frame, mountable retracting blades, and may be intended to attach to a skull clamp (not included). It is typically made of high-grade stainless steel and synthetic polymer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZT	RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K830332	000

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
Device Size Text, specify: 10" Length x 6" Width x 6" Height

Device Record Status

Public Device Record Key: b5ede8b9-8163-4357-b320-bbff7e5b8ba3
Public Version Date: March 19, 2024
Public Version Number: 5
DI Record Publish Date: September 29, 2016