74038876

GUDID 00885556915288

LM/RL TIBIA ALIGNMENT GUIDE SHORT

Smith & Nephew, Inc.

Orthopaedic fixation implant alignment tool
Primary Device ID00885556915288
NIH Device Record Key2efe7bca-d96a-4e6b-8dea-27b075b9819a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number74038876
Catalog Number74038876
Company DUNS045483575
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556915288 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

[00885556915288]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-25
Device Publish Date2024-12-17

Devices Manufactured by Smith & Nephew, Inc.

00885556905463 - NA2024-12-25 INSERT TRIAL PITCHFORK
00885556915288 - NA2024-12-25LM/RL TIBIA ALIGNMENT GUIDE SHORT
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
00885556921449 - Trigen2024-12-04 12.5mm Rigid Entry Reamer
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.