FDA.reportPublic FDA data

Quik-Use®

Primary DI
00889024376649
Brand
Quik-Use®
Company
Zimmer, Inc.
Model
5049-55-10
Published
2016-02-29
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
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024379763PackageGS15In Commercial Distribution
00889024382091PackageGS110In Commercial Distribution
00889024376649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024379763008890243797638890243797630889024379763
00889024382091008890243820918890243820910889024382091
00889024376649008890243766498890243766490889024376649

GMDN Terms#

Term, Definition table
TermDefinition
Polymer orthopaedic cement restrictor, non-bioabsorbableA non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs (e.g., straight or tapered, hollow with a fenestrated surface), and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and it is not intended for spinal application.

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707160G7® Vivacit-E®30104005301040052026-09-30
00889024707184G7® Vivacit-E®30103603301036032026-09-30
00889024707207G7® Vivacit-E®30104407301044072026-09-30
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25

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