NuGrip CMC

Primary DI
00885556857915
Brand
NuGrip CMC
Company
Smith & Nephew, Inc.
Model
TRL-443-10M
Catalog number
TRL-443-10M
Device description
NUGRIP TRIAL SZ. 10M
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYIProsthesis, wrist, carpal trapezium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYIProsthesis, Wrist, Carpal TrapeziumOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112278000ASCENSION NUGRIP CMC IMPLANTAscension Orthopedic2011-11-04KYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556857915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556857915008855568579158855568579150885556857915

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
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
00810063560232Ensemble CMCEnsemble Orthopedics, Inc.KYI2025-05-06
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M209178010THUMB MOD HEAD TITANIUM 12MM+2BIOPRO, INC.KYI2024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MMBIOPRO, INC.KYI2024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2BIOPRO, INC.KYI2024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MMBIOPRO, INC.KYI2024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2BIOPRO, INC.KYI2024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MMBIOPRO, INC.KYI2024-05-30
00810063560201Ensemble CMCEnsemble Orthopedics, Inc.KYI2023-08-01
00885556830789PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830840PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830857PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830864PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830871PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830888PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857748NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857755NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857762NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857779NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857786NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857793NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857809NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857816NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857823NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857922NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857939NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857946NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857953NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857960NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22