71363516

GUDID 03596010467201

FEM CANAL SOUND SIZE 16-17

Smith & Nephew, Inc.

Surgical depth gauge, reusable
Primary Device ID03596010467201
NIH Device Record Key48648d85-c101-4c7c-883f-23166c20e8b7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71363516
Catalog Number71363516
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
GS103596010467201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


[03596010467201]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-09-07
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

23596010587682 - FOOTPRINT2025-01-10 REPLACEMENT END CAPS FOR MALLET SET OF 2
00885556905463 - NA2024-12-25 INSERT TRIAL PITCHFORK
00885556915288 - NA2024-12-25 LM/RL TIBIA ALIGNMENT GUIDE SHORT
00885556921517 - Trigen2024-12-10 Swivel Guide Bolt Wrench
00885556921388 - Legion2024-12-04 Legion AP Cutting Block - Size 8
00885556921395 - Legion2024-12-04 Legion AP Cutting Block - Size 7
00885556921401 - Legion2024-12-04 Legion AP Cutting Block - Size 6
00885556921418 - Legion2024-12-04 Legion AP Cutting Block - Size 5

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.