210438

GUDID 23596010102557

TWIST DRILL 1.6MM DIA 127.0MM LONG

Smith & Nephew, Inc.

Fluted surgical drill bit, reusable
Primary Device ID23596010102557
NIH Device Record Key03af5a34-f4b3-45fa-9bbc-806bb60d9905
Commercial Distribution StatusIn Commercial Distribution
Version Model Number210438
Catalog Number210438
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count6
DM Exempttrue
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
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
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
GS103596010102553 [Unit of Use]
GS123596010102557 [Primary]

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

[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


[23596010102557]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-08-04
Device Publish Date2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

00885556915875 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 4KO VIDIOARTHROSCOPE AC 4 X 30 DEG X 160MM REVERSE POST
00885556915882 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 4KO VIDEOARTHROSCOPE AC 4 X 70 DEG X 160MM REVERSE POST
00885556915899 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
00885556915905 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST
00885556900284 - TRIGEN MAX2025-06-10 TRIGEN MAX 13MM WASHER
00885556901960 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP
00885556901977 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 28MM CORTEX SCREW BLUNT TIP
00885556901984 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 30MM CORTEX SCREW BLUNT TIP

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