FDA.report

ACM BioPrep

Primary DI
34546540055447
Brand
ACM BioPrep
Company
STRYKER CORPORATION
Model
0306708000
Catalog number
0306708000
Device description
Total Joint Kit
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZNCEMENT OBTURATOR

Product Code Classifications

CodeDeviceSpecialtyClass
LZNCement ObturatorGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540055447PackageGS16In Commercial Distribution
04546540055446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654005544734546540055447
04546540055446045465400554464546540055446

GMDN Terms

TermDefinition
Manual orthopaedic cement mixer, reusableA hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

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
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
00889024380189NAZimmer, Inc.LZN2016-08-31
00889024432970NAZimmer, Inc.LZN2016-05-24
00889024432994NAZimmer, Inc.LZN2016-05-24
00889024433014NAZimmer, Inc.LZN2016-05-24
00889024432901N/AZimmer, Inc.LZN2016-02-04
00889024432925N/AZimmer, Inc.LZN2016-02-04
00889024432949N/AZimmer, Inc.LZN2016-02-04
03760177041295MectaPlugTEKNIMEDLZN2015-10-16
03760177041301MectaPlugTEKNIMEDLZN2015-10-16
03760177041318MectaPlugTEKNIMEDLZN2015-10-16
03760177041325MectaPlugTEKNIMEDLZN2015-10-16
03760177041332MECTAPLUGTEKNIMEDLZN2015-10-16
03760177044029MectaPlugTEKNIMEDLZN2015-10-16
03700386922046CEMENT RESTRICTORTORNIERLZN2015-10-16