FDA.reportPublic FDA data

JOURNEY

Primary DI
00885556703632
Brand
JOURNEY
Company
Smith & Nephew, Inc.
Model
74036159
Catalog number
74036159
Device description
CEMENT SCRAPER
Published
2019-06-13
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
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556703632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556703632008855567036328855567036320885556703632

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement curetteA sterile, hand-held, manual surgical instrument designed to remove excess orthopaedic bone cement from an implantation site during the cementing of a prosthesis. It is typically made of plastic materials and consists of a handle proximally and a concave, spoon-like tip that is angled at the distal end, or it may be double-ended with the handle placed centrally. This is a single-use 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034579689N/AMedos International SàrlHTF2026-09-26
10705034579696N/AMedos International SàrlHTF2026-09-26
10705034579702N/AMedos International SàrlHTF2026-09-26
00810238290070PRINCETONPrinceton Medical Group, Inc.HTF2026-09-22
00850088713763PRINCETONPrinceton Medical Group, Inc.HTF2026-09-22
10705034579313N/AMedos International SàrlHTF2026-08-26
10705034579320N/AMedos International SàrlHTF2026-08-26
00850088713589PRINCETONPrinceton Medical Group, Inc.HTF2026-08-25
00190776419646MillenniumAvalign Technologies, Inc.HTF2026-08-23
00190776419653MillenniumAvalign Technologies, Inc.HTF2026-08-23
00190776426408MillenniumAvalign Technologies, Inc.HTF2026-08-18
00850088713435PRINCETONPrinceton Medical Group, Inc.HTF2026-08-14
00850088713442PRINCETONPrinceton Medical Group, Inc.HTF2026-08-14
00190776422240MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422400MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422417MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422424MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422509MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422592MillenniumAvalign Technologies, Inc.HTF2026-07-31
00810168190464NAPACIFIC INSTRUMENTS, INC.HTF2026-07-06
B803PS0099100A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991080ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099108A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991090ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099109A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991100ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099110A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395900ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS03959000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS039590000ORTHOMEDORTHO-MED, INC.HTF2026-06-26