FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912545396
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
800-99-116
Device description
REPLACEMENT DOUBLE LAYER OUTER TRAY
Published
2017-06-27
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170573000Empowr CR Knee Tibial InsertEncore Medical L.P.2017-05-31JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912545396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912545396008889125453968889125453960888912545396

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
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
00190446776550DJO SURGICAL800-99-1632025-01-17
00190446776567DJO SURGICAL800-99-1642025-01-17
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446706304DJO SURGICAL800-99-1482022-10-18
00190446706311DJO SURGICAL800-99-1492022-10-18
00190446706328DJO SURGICAL800-99-1512022-10-18
00190446706335DJO SURGICAL800-99-1522022-10-18
00190446757665DJO SURGICAL800-99-1592022-08-17
00190446757672DJO SURGICAL800-99-1602022-08-17
00190446764274DJO SURGICAL800-99-1612022-08-17
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
00724995296247V. MuellerSteris CorporationFSM2026-08-21
00724995296254V. MuellerSteris CorporationFSM2026-08-21
00724995296261V. MuellerSteris CorporationFSM2026-08-21
00724995296278V. MuellerSteris CorporationFSM2026-08-21
00724995296285V. MuellerSteris CorporationFSM2026-08-21
00724995296292V. MuellerSteris CorporationFSM2026-08-21
00724995296308V. MuellerSteris CorporationFSM2026-08-21
00724995296315V. MuellerSteris CorporationFSM2026-08-21
00724995296322V. MuellerSteris CorporationFSM2026-08-21
00724995296339V. MuellerSteris CorporationFSM2026-08-21
00724995296346V. MuellerSteris CorporationFSM2026-08-21
00724995296353V. MuellerSteris CorporationFSM2026-08-21
00724995296360V. MuellerSteris CorporationFSM2026-08-21
00724995296377V. MuellerSteris CorporationFSM2026-08-21
00724995296384V. MuellerSteris CorporationFSM2026-08-21
00724995296391V. MuellerSteris CorporationFSM2026-08-21
00724995296407V. MuellerSteris CorporationFSM2026-08-21
00724995296414V. MuellerSteris CorporationFSM2026-08-21
00724995296421V. MuellerSteris CorporationFSM2026-08-21
00724995296438V. MuellerSteris CorporationFSM2026-08-21
00724995296445V. MuellerSteris CorporationFSM2026-08-21