FDA.reportPublic FDA data

Protech ™ Trays

Primary DI
00848956000862
Brand
Protech ™ Trays
Company
HEALTHMARK INDUSTRIES CO., INC.
Model
41116H MV
Catalog number
41116H MV
Device description
MAUVE INSTRU TRAY AERATED 11.75W X 16L
Published
2020-09-24
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
00848956000862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848956000862008489560008628489560008620848956000862

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

Regulatory Flags#

DUNS number
057680480
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848956021263Sanizyme60030008332026-05-22
00848956021287Sanizyme60030008352026-05-22
00848956021294Sanizyme60030008362026-05-22
00848956021317Sanizyme60030008342026-05-22
10848956020010SAFEGUARD PROSGP112SGP1122025-10-20
10848956020027SAFEGUARD PROSGP115SGP1152025-10-20
10848956020034SAFEGUARD PROSGP1182025-10-20
10848956020041SAFEGUARD PROSGP124SGP1242025-10-20
10848956020058SAFEGUARD PROSGP130SGP1302025-10-20
10848956020065SAFEGUARD PROSGP136 SGP136 2025-10-20
10848956020072SAFEGUARD PROSGP212 SGP212 2025-10-20
10848956020089SAFEGUARD PROSGP218SGP2182025-10-20
10848956020096SAFEGUARD PROSGP224SGP2242025-10-20
10848956020102SAFEGUARD PROSGP230 SGP230 2025-10-20
10848956020119SAFEGUARD PROSGP236 SGP236 2025-10-20
10848956020126SAFEGUARD PROSGP324SGP3242025-10-20
10848956020133SAFEGUARD PROSGP330SGP3302025-10-20
10848956020140SAFEGUARD PROSGP336 SGP336 2025-10-20
10848956020157SAFEGUARD PROSGP345SGP3452025-10-20
10848956020164SAFEGUARD PROSGP354 SGP354 2025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111228428Instrument TrayTreace Medical Concepts, Inc.FSM2026-10-16
00810161900909EARP IMPLANT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900916EARP INSTRUMENT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900923EARP INSTRUMENT AND IMPLANT LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900930EARP RETRACTOR TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900947EARP RETRACTOR LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900954EARP, TRIAL CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900961EARP, TRIAL LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900978EARP, DISC SPACER CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900985EARP, DISC SPACER LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901746EARP INSTRUMENT #2 TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901753EARP INSTRUMENT #2 LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901814EARP, PLATFORM CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901821EARP, PLATFORM LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
04042409457203CHBSaap Implantate AGFSM2026-10-16
04042409457289CHBSaap Implantate AGFSM2026-10-16
04042409457302CHBSaap Implantate AGFSM2026-10-16
04042409457326CHBSaap Implantate AGFSM2026-10-16
04042409457340CHBSaap Implantate AGFSM2026-10-16
05055662966855Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-10-16
05055662966862Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-10-16
00724995239992V. MuellerSteris CorporationFSM2026-10-15
00724995240004V. MuellerSteris CorporationFSM2026-10-15
00724995240011V. MuellerSteris CorporationFSM2026-10-15
00724995240028V. MuellerSteris CorporationFSM2026-10-15
00724995243401V. MuellerSteris CorporationFSM2026-10-15
00889795150271APEX 3D Total Ankle Replacement SystemParagon 28, Inc.FSM2026-10-12
00190446960386Active AdaptiveMedshape, Inc.FSM2026-10-09
00850045406615clamp-itGeneral Hospital Supply CorpFSM2026-10-01
00190776434588MillenniumAvalign Technologies, Inc.FSM2026-09-30