FDA.report

DJO SURGICAL

Primary DI
00190446138105
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
600-55-510
Device description
OPTIVAC KNEE CEMENT NOZZLE 10PK
Published
2022-04-26
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

Related Records

Product Codes

CodeName
KIHDISPENSER, CEMENT

Product Code Classifications

CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446138105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446138105001904461381051904461381050190446138105

GMDN Terms

TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
154074504
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
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

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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
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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
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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
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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