Speed Triad

GUDID 00810633021613

Speed Triad 18X15X08mm 3 Legs, centered

Biomedical Enterprises, Inc.

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable
Primary Device ID00810633021613
NIH Device Record Key8c3c8f0b-2ed7-422e-a660-2263da6c6017
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeed Triad
Version Model NumberSE-181508TRC
Company DUNS792619009
Company NameBiomedical Enterprises, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-881-0064
Emailaknight@bme-tx.com
Phone210-881-0064
Emailaknight@bme-tx.com
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Dimensions

Width18 Millimeter
Width18 Millimeter
Width18 Millimeter
Width18 Millimeter
Width18 Millimeter
Width18 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100810633021613 [Primary]

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-07
Device Publish Date2015-10-24

On-Brand Devices [Speed Triad]

00810633021668Speed Triad Implant Sizing Guide
00810633021651Speed Triad Drill Kit
00810633021644Speed Triad 20X15X08mm 3 Legs, centered
00810633021637Speed Triad 20X15X08mm 3 Legs, right offset
00810633021620Speed Triad 20X15X08mm 3 Legs, left offset
00810633021613Speed Triad 18X15X08mm 3 Legs, centered
00810633021606Speed Triad 18X15X08mm 3 Legs, right offset
00810633021590Speed Triad 18X15X08mm 3 Legs, left offset
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.