210451

GUDID 23596010102687

TWIST DRILL 3.5MM DIA 152.4MM LONG

Smith & Nephew, Inc.

Fluted surgical drill bit, reusable
Primary Device ID23596010102687
NIH Device Record Key9d3f1462-1737-415e-8430-4f77872dc6d4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number210451
Catalog Number210451
Company DUNS045483575
Company NameSmith & Nephew, 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 Usefalse
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

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010102683 [Primary]
GS123596010102687 [Package]
Contains: 03596010102683
Package: BX [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


[23596010102687]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-09-07
Device Publish Date2015-08-29

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