3.5mm Interlocking Bone Screw Fastener 335-1058

GUDID 00816950020469

58 mm, 3.5mm Interlocking Bone Screw Fastener, Self-Tapping

SMV SCIENTIFIC LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950020469
NIH Device Record Keyb72264fc-5f75-4d40-950a-299330e4957b
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm Interlocking Bone Screw Fastener
Version Model Number335-1058
Catalog Number335-1058
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
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

Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com

Device Dimensions

Length58 Millimeter
Length58 Millimeter
Length58 Millimeter
Length58 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950020469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950020469]

Moist Heat or Steam Sterilization


[00816950020469]

Moist Heat or Steam Sterilization


[00816950020469]

Moist Heat or Steam Sterilization


[00816950020469]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-24

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