FDA.reportPublic FDA data

Spetzler® Micro Dissection Set, Tray #2

Primary DI
00840096203899
Brand
Spetzler® Micro Dissection Set, Tray #2
Company
KATALYST SURGICAL LLC
Model
N079-SET
Published
2019-07-09
Public version status
Update
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
00840096203899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096203899008400962038998400962038990840096203899

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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1084009621336927ga Stiff MultiFlex Inverted Extendable Laser Probe, Quantel ConnectorV6520E-27C2020-10-27
1084009621337627ga Stiff MultiFlex Inverted Extendable Laser Probe, Nidek ConnectorV6520E-27E2020-10-27
1084009621338327ga Stiff MultiFlex Inverted Extendable Laser Probe, Dorc ConnectorV6520E-27J2020-10-27
1084009621395625ga Illuminated MultiFlex™ Laser Probe, DORC ConnectorV6351-25JR2021-01-07
0084009620650023ga ISOCLEAN™ Micro Tying Forceps Gold3850S-M23G2020-05-27
0084009620676023ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft, Gold6850C-M23G2020-06-01
00840096208276Revolver Universal ConnectorRLP-A2020-06-08
00840096208283Constellation Illumination AdapterRLP-Q2020-06-10
00840096208290Stellaris Illumination AdapterRLP-S2020-06-10
00840096208306DORC Illumination AdapterRLP-U2020-06-10
00840096208313Short 19ga Needle Illumination AdapterRLP-V2020-06-10
0084009621284623ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft6850C-M232020-06-18
00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10817489024536Revolver FiberV66002019-07-17
10817489024833Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5DKIF7-05S2017-03-22
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10817489024857Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5DKIF7-15S2017-03-22
10817489024864Disposable Bipolar Focused Irrigating Forceps, 8", 0.5mm Straight Tips, Box of 5DKIF8-05S2017-03-22

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