FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446283669
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
600-60-002
Device description
CEMENTATION SYSYTEM OPTIGUN RATCHET
Published
2021-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
KIHDISPENSER, CEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446283669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446283669001904462836691904462836690190446283669

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
DM exempt
true
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446839187DJO SURGICAL804-06-4182024-06-27
00190446839194DJO SURGICAL804-06-4192024-06-27
00190446839200DJO SURGICAL804-06-3182024-06-27
00190446839217DJO SURGICAL804-06-3192024-06-27
00190446905998DJO SURGICAL800-05-2142026-03-03
00190446960515DJO SURGICALS-2019612026-02-17
00190446905950DJO SURGICAL800-05-2102026-02-11
00190446905974DJO SURGICAL800-05-2112026-02-11
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446906117DJO SURGICAL801-05-2122026-02-11
00190446924470DJO SURGICALS-2019282025-10-10
00190446946007DJO SURGICALS-2019562025-12-11
00190446893332DJO SURGICAL941-01-32B2025-12-04
00190446893349DJO SURGICAL941-01-36D2025-12-04
00190446893356DJO SURGICAL941-01-40F2025-12-04
00190446893363DJO SURGICAL941-01-44H2025-12-04
00190446893370DJO SURGICAL942-01-32B2025-12-04
00190446893387DJO SURGICAL942-01-36D2025-12-04
00190446893394DJO SURGICAL942-01-40F2025-12-04
00190446893400DJO SURGICAL942-01-44H2025-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053617183750PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183767PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183774PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183781PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183798PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183804PressurizerADLER ORTHO SPAKIH2025-08-07
08053617184498PressurizerADLER ORTHO SPAKIH2025-08-07
06951233720842PALAGUN®Guangzhou Clean Medical Products Manufacturing Corp.KIH2025-06-05
00763000883461N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883478N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883485N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000242510MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.KIH2025-05-11
25060238201630HiVac™ 7 Triple Mix SUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201654HiVac™ 7 with Femoral Cement Pressuriser SUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201678HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201685HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
250602382017159mm Nozzle With Nozzle ExtruderSUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201777Cement Mixing and Delivery SystemSUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201807MiniMix™ Delivery SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
00763000711993N/AMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
00763000712006N/AMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
00763000712013N/AMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
00763000712020n/aMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
08058964726841Flex FillerG21 SRLKIH2024-10-10
250602382016096mm Slim Flexible NozzleSUMMIT MEDICAL LIMITEDKIH2024-05-22
25060238201616HiVac™ 7SUMMIT MEDICAL LIMITEDKIH2024-05-20
08800104078415AnyPlus®GS Medical Co., Ltd.KIH2024-05-02
25060238201357SmartMix™ Vacuum SyringeSUMMIT MEDICAL LIMITEDKIH2024-04-26
25060238201364SmartMix™ Vacuum Syringe PlusSUMMIT MEDICAL LIMITEDKIH2024-04-26
25060238201418SmartMix™ Syringe KitSUMMIT MEDICAL LIMITEDKIH2024-04-26