Bioplate@ 81-3595[US]

GUDID M384813595US0

5-Tab Zip Implant - 16 mm

Bioplate, Inc

Cranioplasty plate, non-alterable
Primary Device IDM384813595US0
NIH Device Record Keye4b9c94c-64e6-48db-ba4f-7d9273530dcd
Commercial Distribution Discontinuation2022-02-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBioplate@
Version Model Number81-3595[US]
Catalog Number81-3595[US]
Company DUNS838734093
Company NameBioplate, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com
Phone888-246-7528
EmailINFO@bioplate.com

Device Dimensions

Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM384813595US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

[M384813595US0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-02-02
Device Publish Date2016-06-10

On-Brand Devices [Bioplate@]

M384P3ST16860Straight Plate - Ø1.9 mm - 16 hole - 86 mm
M384P3SB04200Straight Plate - Ø1.9 mm - 4 hole - 20 mm
M384P3SB0212051Straight Plate - Ø1.9 mm - 2 hole - 12 mm [5 PK]
M384P2SB04210Xpress ® Straight Plate - Ø1.5 mm - 4 hole - 21 mm
M38481359605-Tab Zip Implant - 20 mm
M384813595US05-Tab Zip Implant - 16 mm
M38481359505-Tab Zip Implant - 16 mm
M38481359405-Tab Zip Implant - 12 mm
M3848135181Zip® Implant - 20 mm (STERILE) [6 PK]
M3848135171Zip® Implant - 16 mm (STERILE) [6 PK]
M3848135161Zip® Implant - 12 mm (STERILE) [6 PK]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.