AccessGUDID - DEVICE: Bioplate® (M384813580US0)

GUDID

Device Identifier (DI) Information

Brand Name: Bioplate®
Version or Model: 81-3580[US]
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 81-3580[US]
Company Name: Bioplate, Inc.

Primary DI Number: M384813580US0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 838734093 *Terms of Use

Device Description: Flexible Burr Hole Cover - Ø1.5 mm - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEY	Plate, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082757	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ff5f523-6809-4d69-8f1a-61c895009e4d
Public Version Date: February 23, 2022
Public Version Number: 4
DI Record Publish Date: May 27, 2016