Bioplate@ P2SB-04-21

GUDID M384P2SB04210

Xpress ® Straight Plate - Ø1.5 mm - 4 hole - 21 mm

Bioplate, Inc

Craniofacial fixation plate, non-bioabsorbable
Primary Device IDM384P2SB04210
NIH Device Record Key544fb751-c053-4c5a-a1bb-309cea99f036
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioplate@
Version Model NumberP2SB-04-21
Catalog NumberP2SB-04-21
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
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

Length21 Millimeter
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Length21 Millimeter
Length21 Millimeter
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Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
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Length21 Millimeter
Length21 Millimeter
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Length21 Millimeter
Length21 Millimeter
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Length21 Millimeter
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Length21 Millimeter
Length21 Millimeter
Length21 Millimeter
Length21 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM384P2SB04210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPlate, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

[M384P2SB04210]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-05
Device Publish Date2018-10-30

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]
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