FDA.reportPublic FDA data

Avitus Surgical Tray

Primary DI
00857373006135
Brand
Avitus Surgical Tray
Company
AVITUS ORTHOPAEDICS, INC.
Model
ST-01
Catalog number
ST-01
Device description
Surgical tray to store the PH11, and other Avitus devices intended for the tray, during sterilization, aseptic presentation, and transportation within the hospital.
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00857373006135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857373006135008573730061358573730061350857373006135

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

Contacts#

Phone, Email table
PhoneEmail
8606379922neil@avitusortho.com
8603727213maxim@avitusortho.com

Regulatory Flags#

DUNS number
078269403
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
00857373006012Avitus Pilot Hole Creator, Disposable - 8mmPC-200PC-2002022-12-08
00857373006067Avitus Pilot Hole Creator, Disposable - 11mmPC-100PC-1002022-12-08
00857373006104Avitus Pilot Hole Creator - 11mmPH11PH112022-12-08
00857373006142Avitus ® Bone DebriderTM – Ø8mm, 255mm Shaft LengthBH-330BH-3302024-07-08
00857373006128DragonWingAD-5ch-5.2-120AD-5ch-5.2-1202023-08-28
00857373006111ArchiMISAD-1ch-4.0-120AD-1ch-4.0-1202023-07-19
00857373006074Avitus Bone HarvesterBH-220BH-2202020-10-08
00857373006005Avitus Bone HarvesterBH8BH82016-05-23
00857373006029Avitus Bone HarvesterFI-100FI-1002017-11-07
00857373006036Avitus Bone HarvesterBH-210BH-2102017-11-03
00857373006050Avitus Bone HarvesterBH-110BH-1102018-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD923300150Surgical DirectSurgical Direct, Inc.FSM2026-08-07
B382SD923301040Surgical DirectSurgical Direct, Inc.FSM2026-08-07
00840606192002Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192019Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192026Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192033Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192040Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194884Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194891Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194907Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194914Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194921Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194938Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194945Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194952Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194969Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194976Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194983Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194990Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195003Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195010Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195027Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195034Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195041Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195058Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195065Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195539Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195669Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195676Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195683Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31