FDA.report

PCD

Primary DI
34546540906992
Brand
PCD
Company
STRYKER CORPORATION
Model
0506482000
Catalog number
0506482000
Device description
Precision System with Needle
Published
2018-09-24
Public version status
New
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
OARInjector, vertebroplasty (does not contain cement)

Product Code Classifications

CodeDeviceSpecialtyClass
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540906992PackageGS14In Commercial Distribution
04546540906991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654090699234546540906992
04546540906991045465409069914546540906991

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.

Device Sizes

TypeValueUnit
Needle Gauge10Gauge

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
true
HCT/P
false
Kit
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08053175003439Vertebroplasty Injector KitADRIA SRLOAR2025-04-07
08053175004382Cement Injection CannulaADRIA SRLOAR2025-04-07
03701505801075PUREKIT SyringesTEKNIMEDOAR2025-03-31
03701505801082Syringes 4ccTEKNIMEDOAR2025-03-31
03701505801099Syringes 1.5ccTEKNIMEDOAR2025-03-31
10884450837549StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
10884450833961DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
00815212026935Duro-Ject Bone Cement Injection TubeIzi Medical Products, LLCOAR2024-10-14
08058964724960VHP GUNG21 SRLOAR2024-10-14
08033860022693BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
08800038054332MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038054349MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038055674SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
08800038055681SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
00884450492284StabiliT®Merit Medical Systems, Inc.OAR2023-07-08
08033860015435BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860017521BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860022419BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860023102BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860026592BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860034740BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860039417BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
10884450662141StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2022-10-04
08033860030223BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860036591BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860024567BIOPSYBELLBIOPSYBELL SRLOAR2022-09-28
28031497001702MENDEC AQUATECRES SPAOAR2022-09-23
28031497002006MENDEC AQUA CARTRIDGE TECRES SPAOAR2022-09-23
08033860016739BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19
08033860016760BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19