FDA.reportPublic FDA data

Instrument Tray

Primary DI
00810111225458
Brand
Instrument Tray
Company
Treace Medical Concepts, Inc.
Model
02-00482
Device description
Percuplasty Targeting Jig Tray
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00810111225458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111225458008101112254588101112254580810111225458

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054808082
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111227353ScalpelSN562026-06-05
00810111227292K-Wire02-005432026-06-02
00810111227346Scalpel 02-003872026-05-19
00810111227223SpeedMTP SelectSK692026-05-13
00810111227247SpeedMTP SelectSD342026-05-13
00810111227254SpeedMTP SelectSD332026-05-13
00810111225663X-ray App12-000012026-05-01
00810111226769ReamerSN502026-05-01
00810111226776ReamerSN512026-05-01
00810111226783ReamerSN522026-05-01
00810111227261K-Wire02-005202026-04-27
00810111224987Screwdriver02-004402026-04-15
00810111225007Screwdriver02-004422026-04-15
00810111225021Screwdriver02-004442026-04-15
00810111225069Screwdriver02-004482026-04-15
00810111225670Screwdriver02-005062026-04-15
00810111225687Percuplasty SuperBite Compression ScrewSC701302026-04-15
00810111225694Percuplasty SuperBite Compression ScrewSC701252026-04-15
00810111225700Percuplasty SuperBite Compression ScrewSC701202026-04-15
00810111225717Percuplasty SuperBite Compression ScrewSC701152026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
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