NuGrip CMC

Primary DI
00885556857793
Brand
NuGrip CMC
Company
Smith & Nephew, Inc.
Model
NUG-443-30M
Catalog number
NUG-443-30M
Device description
NUGRIP SZ. 30M
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00885556857793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556857793008855568577938855568577930885556857793

GMDN Terms#

Term, Definition table
TermDefinition
Carpal trapezium prosthesisA sterile implantable device designed to replace a partly-resected trapezium bone of the wrist typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device made of silicone elastomer. Short-term fixation is typically performed with sutures.

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810063560232Ensemble CMCEnsemble Orthopedics, Inc.KYI2025-05-06
M209177990THUMB MOD HEAD TITANIUM 13MM+2BIOPRO, INC.KYI2024-06-30
M209178000THUMB MOD HEAD TITANIIUM 12MMBIOPRO, INC.KYI2024-06-30
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
00885556857809NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857816NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857823NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857915NuGrip 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