FDA.reportPublic FDA data

ULTRABRACE

Primary DI
00885556890752
Brand
ULTRABRACE
Company
Smith & Nephew, Inc.
Model
72205500
Catalog number
72205500
Device description
ULTRABRACE KIT
Published
2024-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, nonabsorbable, synthetic, polyethylene
HTWBIT, DRILL
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
HTWBit, DrillOrthopedic1
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232457000Q-FIX ULTRA All-Suture AnchorSmith & Nephew2023-09-08MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556890752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556890752008855568907528855568907520885556890752

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556833933Salto Talaris Total Ankle ProsthesisMJU952TMJU952T2022-12-22
00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258654799Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
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07899258654829Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258657141Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665764Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665771Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665795Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665863Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665870Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665894Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665962Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665986Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697864Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697871Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697888Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697895Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697901Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698038Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698045Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698052Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698069Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698076Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
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07899258698090Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
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07899258698113Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
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