FDA.reportPublic FDA data

NA

Primary DI
07613327051285
Brand
NA
Company
STRYKER CORPORATION
Model
0306703000
Catalog number
0306-703-000
Device description
ACM w/ nozzle restr/press
Published
2015-09-24
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
LZNCEMENT OBTURATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZNCement ObturatorGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327051286PackageGS16In Commercial Distribution
07613327051285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332705128637613327051286
07613327051285076133270512857613327051285

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760177046542CLEARCUTTEKNIMEDLZN2020-11-25
03760177046573CLEARCUTTEKNIMEDLZN2020-11-25
03760177046603CLEARCUTTEKNIMEDLZN2020-11-25
03760177046634CLEARCUTTEKNIMEDLZN2020-11-25
03760177046665CLEARCUTTEKNIMEDLZN2020-11-25
03760177046696CLEARCUTTEKNIMEDLZN2020-11-25
03760177046535CLEARCUTTEKNIMEDLZN2020-09-24
00889024510326NAZimmer, Inc.LZN2018-09-14
00889024510333NAZimmer, Inc.LZN2018-09-14
00889024510340NAZimmer, Inc.LZN2018-09-14
00889024510357NAZimmer, Inc.LZN2018-09-14
00889024510364NAZimmer, Inc.LZN2018-09-14
00889024510371NAZimmer, Inc.LZN2018-09-14
00888912023443DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023450DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023467DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023474DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023481DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912073806DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00889024376724NAZimmer, Inc.LZN2016-08-31
00889024376748NAZimmer, Inc.LZN2016-08-31
00889024376755NAZimmer, Inc.LZN2016-08-31
00889024380189NAZimmer, Inc.LZN2016-08-31
00889024432918NAZimmer, Inc.LZN2016-07-15
00889024432970NAZimmer, Inc.LZN2016-05-24
00889024432987NAZimmer, Inc.LZN2016-05-24
00889024432994NAZimmer, Inc.LZN2016-05-24
00889024433007NAZimmer, Inc.LZN2016-05-24
00889024433014NAZimmer, Inc.LZN2016-05-24
00889024433021NAZimmer, Inc.LZN2016-05-24