013571

GUDID 03596010091185

RASP RND HF 8MM

Smith & Nephew, Inc.

Bone file/rasp, manual
Primary Device ID03596010091185
NIH Device Record Key615cfe1a-19a9-4f25-8473-81b6ad883ffd
Commercial Distribution StatusIn Commercial Distribution
Version Model Number013571
Catalog Number013571
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)821-5700
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
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
GS103596010091185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


[03596010091185]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-31
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

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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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