AccessGUDID - DEVICE: Bioplate® (M3848135160)

GUDID

Device Identifier (DI) Information

Brand Name: Bioplate®
Version or Model: 81-3516
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 81-3516
Company Name: Bioplate, Inc.

Primary DI Number: M3848135160
Issuing Agency: HIBCC
Commercial Distribution End Date: February 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 838734093 *Terms of Use

Device Description: Zip® Implant - 12 mm (STERILE) [6 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?
46268	Cranioplasty plate, non-alterable	An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXN	Plate, Cranioplasty, Preformed, Non-Alterable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070901	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: bf83a213-41e6-4380-b6eb-5841d61f9eef
Public Version Date: September 12, 2023
Public Version Number: 7
DI Record Publish Date: December 03, 2015