AccessGUDID - DEVICE: Bioplate® (M3848173070)

GUDID

Device Identifier (DI) Information

Brand Name: Bioplate®
Version or Model: 81-7307
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 81-7307
Company Name: Bioplate, Inc.

Primary DI Number: M3848173070
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 838734093 *Terms of Use

Device Description: Straight Plate - Ø1.9 mm - 2 hole - 15 mm (3), Self-Drilling Screw - 4 mm (6) [10 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: cbe3b63f-9e97-41cb-8fa6-766d0f3548cc
Public Version Date: February 23, 2022
Public Version Number: 2
DI Record Publish Date: July 13, 2021