ULTRABRACE 72205500

GUDID 00885556890752

ULTRABRACE KIT

Smith & Nephew, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00885556890752
NIH Device Record Key82e859de-c44d-4546-b06e-fdb9d8110b17
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRABRACE
Version Model Number72205500
Catalog Number72205500
Company DUNS045483575
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556890752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, fixation, nondegradable, soft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-06
Device Publish Date2024-04-26

Devices Manufactured by Smith & Nephew, Inc.

00885556902738 - INTELLIO SHIFT2024-05-15 NEO CONTROLLER REFURBISH
00885556630761 - Q-FIX2024-05-14 DISPOSABLE 1.8MM Q-FIX DRILL
00885556630785 - Q-FIX2024-05-14 REUSABLE 1.8MMQ-FIX DRILL GUIDE
00885556918333 - R32024-05-10 FEMORAL OSTEOTOMY RULER
00885556817667 - TULA2024-05-07 TULA KIT- UNILATERAL (NST007068)
00885556890745 - Q-FIX2024-05-06 Q-FIX ULTRA
00885556890752 - ULTRABRACE2024-05-06ULTRABRACE KIT
00885556890752 - ULTRABRACE2024-05-06 ULTRABRACE KIT
00885556890769 - FOOTPRINT2024-05-06 FOOTPRINT MINI PK 3.5MM

Trademark Results [ULTRABRACE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRABRACE
ULTRABRACE
97765874 not registered Live/Pending
Smith & Nephew, Inc.
2023-01-24
ULTRABRACE
ULTRABRACE
90006388 not registered Live/Pending
Smith & Nephew, Inc.
2020-06-17
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.