210064

GUDID 03596010101723

SUPER-BITE PIN CUTTER

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID03596010101723
NIH Device Record Key28d11c1c-1512-4268-87ea-9c8a4410d6a2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number210064
Catalog Number210064
Company DUNS109903521
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
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
GS103596010101723 [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

[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


[03596010101723]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-03
Device Publish Date2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

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00885556906606 - EVOS2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 6 HOLE
00885556906613 - EVOS2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 7 HOLE
00885556906620 - EVOS2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 8 HOLE
00885556906637 - EVOS2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 10 HOLE
00885556906644 - EVOS2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 12 HOLE
00885556906651 - EVOS2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 14 HOLE

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