FDA.reportPublic FDA data

#4- General Purpose Elevator, Small, Straight, Blunt, Length 191mm, Angular, 1.2

Primary DI
00840096204544
Brand
#4- General Purpose Elevator, Small, Straight, Blunt, Length 191mm, Angular, 1.2
Company
KATALYST SURGICAL LLC
Model
N7104-K
Device description
#4- General Purpose Elevator, Small, Straight, Blunt, Length 191mm, Angular, 1.2mm Tip
Published
2020-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTEElevator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096204544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096204544008400962045448400962045440840096204544

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
Manufacturing date on label
true
Sterilization required before use
true

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00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10840096211365Cili Probes (Cyclophotocoagulation)6202312020-03-04
10817489025298Cyclophotocoagulation Probe, Quantel ConnectorXLCYCLO2018-12-11
10817489025304Cyclophotocoagulation Probe, Iridex ConnectorXLCYCLOA2018-12-11
10817489025151Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700A2017-07-21
10817489025168Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700C2017-07-21
1084009621532527ga Stiff Slim DEX™ NanoTapered™ Awh ForcepsDVFO4005-272025-10-06
00840096214987Curved Up Micro Scissors, 11mm Blades, Bayonet Round Handle, 230mmN61062025-09-10
1081748902356020ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-20AR2020-11-25
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-20BR2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-20CR2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-20ER2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCV6300-20JR2020-11-27
1081748902361423ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-23AR2020-11-25
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-23BR2020-11-27
1081748902363823ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-23CR2020-11-27
1081748902364523ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-23ER2020-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811078988INKAThe Trustee for KAISER FAMILY TRUSTHTE2026-03-18
10840199507723SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507730SeparatorKOROS U.S.A., INC.HTE2024-12-31
10840199507747ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507754ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507761ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507778ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507785ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507792ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507808ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507815ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507877ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199507969ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511447ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199511454ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526540ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199526557ElevatorKOROS U.S.A., INC.HTE2024-12-31
10840199545558ElevatorKOROS U.S.A., INC.HTE2024-02-05
10840199527288ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527295ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527301ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527318ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527325ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527332ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527349ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199527356ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199528315ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529077Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529084Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31
10840199529091Comfort Plus Cobb ElevatorKOROS U.S.A., INC.HTE2024-01-31