AccessGUDID - DEVICE: Davida Neurosurgery Retractor and Hand Stabilization Systems (00842102100086)

GUDID

Device Identifier (DI) Information

Brand Name: Davida Neurosurgery Retractor and Hand Stabilization Systems
Version or Model: 69024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 69024
Company Name: FLEXBAR MACHINE CORPORATION

Primary DI Number: 00842102100086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047644935 *Terms of Use

Device Description: Davida Instrument Holder Micro Holds up to 1/8" (3mm)

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?
32560	Neurosurgical retractor, self-retaining	A surgical instrument for separating and/or drawing aside nervous system structures or other tissues to permit examination or intervention. Once set, this retractor maintains its set position. It is made of high-grade stainless steel. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GZT	Retractor, Self-Retaining, For Neurosurgery

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
No Device Sizes

Device Record Status

Public Device Record Key: ccd29639-36e5-4c96-9e2a-b3bee1df84f4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016