FDA.reportPublic FDA data

Precision Tray

Primary DI
09351290000067
Brand
Precision Tray
Company
CRYPTYCH PTY LTD
Model
CRY03
Catalog number
CRY-03
Published
2018-12-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19351290000064PackageGS11In Commercial Distribution
09351290000067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1935129000006419351290000064
09351290000067093512900000679351290000067

GMDN Terms#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
742846228
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351290000074Precision ScrewCRY01-H3-1ECRY01-H3-1E2016-10-18
09351290000081Precision ScrewCRY01-H4-1ECRY01-H4-1E2018-12-10
09351290000043Precision DriverCRY02-H3CRY02-H32018-12-10
09351290000050Precision DriverCRY02-H4CRY02-H42018-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956461994CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956463110CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
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