Bioplate@ P3SB-02-12-05

GUDID M384P3SB0212051

Straight Plate - Ø1.9 mm - 2 hole - 12 mm [5 PK]

Bioplate, Inc

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized
Primary Device IDM384P3SB0212051
NIH Device Record Key19be9fd6-f57f-4972-95bd-a76e33f21ae5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioplate@
Version Model NumberP3SB-02-12-05
Catalog NumberP3SB-02-12-05
Company DUNS838734093
Company NameBioplate, Inc
Device Count5
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
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

Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM384P3SB0212050 [Unit of Use]
HIBCCM384P3SB0212051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPlate, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

[M384P3SB0212051]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-05
Device Publish Date2018-10-29

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.