FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446293682
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
803-99-113
Device description
EMPOWR ACETABULAR SYSTEM, CORE REAMER TRAY
Published
2019-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446293682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446293682001904462936821904462936820190446293682

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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
00888912024884DJO SURGICAL520-00-0002017-08-07
00190446263906DJO SURGICAL354-10-0402018-07-16
00190446264156DJO SURGICAL354-10-0652018-07-16
00190446264163DJO SURGICAL354-12-0402018-07-16
00190446264170DJO SURGICAL354-12-0652018-07-16
00190446264187DJO SURGICAL354-14-0402018-07-16
00190446264194DJO SURGICAL354-14-0652018-07-16
00190446978213DJO SURGICALS-2019692026-05-01
00190446978268DJO SURGICALS-2019702026-05-01
00190446978275DJO SURGICALS-2019712026-05-01
00190446978282DJO SURGICALS-2019722026-05-01
00888912078634DJO SURGICAL425-97-0052017-08-07
00888912078641DJO SURGICAL425-97-0062017-08-07
00888912078658DJO SURGICAL425-97-0072017-08-07
00888912078665DJO SURGICAL425-97-0082017-08-07
00888912078672DJO SURGICAL425-97-0092017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
07630894802973APTUSMedartis AGFSM2023-02-24
07630894802980APTUSMedartis AGFSM2023-02-24
07630894802997APTUSMedartis AGFSM2023-02-24
07630894803208APTUSMedartis AGFSM2023-02-24
07630894803215APTUSMedartis AGFSM2023-02-24
07630894803222APTUSMedartis AGFSM2023-02-24
07630894803246APTUSMedartis AGFSM2023-02-24
07630894803260APTUSMedartis AGFSM2023-02-24
07630894803307APTUSMedartis AGFSM2023-02-24
07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24
07630894803338APTUSMedartis AGFSM2023-02-24
07630894803345APTUSMedartis AGFSM2023-02-24
07630894803369APTUSMedartis AGFSM2023-02-24
07630894803383APTUSMedartis AGFSM2023-02-24
07630894803390APTUSMedartis AGFSM2023-02-24
07630894803413APTUSMedartis AGFSM2023-02-24