71050001

GUDID 03596010454430

HEIDELBERG SHORT CENTRAL BODY

Smith & Nephew, Inc.

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable
Primary Device ID03596010454430
NIH Device Record Key2fee540d-3e25-42fb-b2b5-fb44bbcbad51
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71050001
Catalog Number71050001
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
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010454430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


[03596010454430]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-11-03
Device Publish Date2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

00885556817667 - TULA2024-05-07 TULA KIT- UNILATERAL (NST007068)
00885556890745 - Q-FIX2024-05-06 Q-FIX ULTRA
00885556890752 - ULTRABRACE2024-05-06 ULTRABRACE KIT
00885556890769 - FOOTPRINT2024-05-06 FOOTPRINT MINI PK 3.5MM
00885556890790 - Q-FIX2024-05-06 2.9MM CANNULATED DRILL FOR Q-FIX ULTRA & 1.25MM DRILL PIN
00885556890912 - FOOTPRINT2024-05-06 FOOTPRINT MINI DRILL 3.5MM
00885556901335 - FOOTPRINT2024-05-06 FOOTPRINT MINI DRILL 3.7MM
20885556817692 - TULA2024-05-06 TULA EARPLUG 10-PACK- SIZE 2 (NST007071)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.