FDA.reportPublic FDA data

Tray, Surgical Instrument

Primary DI
00628678764019
Brand
Tray, Surgical Instrument
Company
Conkin Surgical Instruments Ltd
Model
ST-6
Published
2023-06-26
Public version status
New
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
00628678764019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628678764019006286787640196286787640190628678764019

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

Regulatory Flags#

DUNS number
257261032
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00627843701781Valtchev Uterine MobilizerVUM-6VUM-62016-09-24
00627843701798Valtchev Uterine Mobilizer15A15A2016-09-24
00627843701804Valtchev Uterine Mobilizer16A16A2016-09-24
00627843701811Valtchev Uterine Mobilizer17172016-09-24
00627843701828Valtchev Uterine Mobilizer18182016-09-24
00627843701835Valtchev Uterine Mobilizer19192016-09-24
00627843701842Valtchev Uterine Mobilizer20202016-09-24
00627843701859Valtchev Uterine MobilizerVTVT2016-09-24
00627843701866Valtchev Uterine Mobilizer9A9A2016-09-24
00627843701873Valtchev Uterine Mobilizer882016-09-24
10627843701788Valtchev Uterine MobilizerVUM-6VUM-62016-09-24

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