FDA.reportPublic FDA data

Apyx®

Primary DI
10607151050242
Brand
Apyx®
Company
APYX MEDICAL CORPORATION
Model
APYX-BRUSH-1
Catalog number
APYX-BRUSH-1
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GECBrush, Scrub, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GECBrush, Scrub, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151050242PrimaryGS10
00607151050245Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715105024210607151050242
00607151050245006071510502456071510502450607151050245

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
101223287
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607151051006AYON™ Power Liposuction Tubing AdaptorAYON-PL-ADPT2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAYON-PL-00012026-05-14
00607151057015AYON™ Power Liposuction CableAYON-PL-00022026-05-14
00607151050504AYON ConsoleAYON-CONSOLE2025-06-03
00607151050481AYON Wireless FootswitchAYON-FSW-00012025-05-29
00607151050498AYON Base TowerAYON-TOWER2025-05-29
00607151050511AYON Base Tower AYON-TOWER2025-05-29
00607151050528AYON Infiltration Handle AYON-IF-00012025-05-29
00607151050535AYON Infiltration Handle on/offAYON-IF-00022025-05-29
00607151050559AYON Ultrasound Assisted Liposuction Handpiece AYON-UAL-00012025-05-29
00607151050566AYON Ultrasound Assisted Liposuction Cable AYON-UAL-00022025-05-29
00607151050573AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 5 ringsAYON-UAL-3733-52025-05-29
00607151050580AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 5 ringsAYON-UAL-3726-52025-05-29
00607151050597AYON Ultrasound Assisted Liposuction Probe: 2.9mm diameter, 26cm length, 5 ringAYON-UAL-2926-52025-05-29
00607151050603AYON Ultrasound Assisted Liposuction Probe: 2.9mm diameter, 18cm length, 5 ringsAYON-UAL-2918-52025-05-29
00607151050610AYON Ultrasound Assisted Liposuction Probe: 2.2mm diameter, 18cm length, 3 ringsAYON-UAL-2218-32025-05-29
00607151050665AYON Skin Port Small 3mmAYON-SP-SMALL2025-05-29
00607151050672AYON Skin Port Large 5mmAYON-SP-LARGE2025-05-29
00607151050689AYON Skin Port CorckscrewAYON-SP-CKS2025-05-29
00607151050696AYON Skin Port ToolAYON-SP-TOOL2025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10620974004483Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974004490Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974004551Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974004568Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974001338Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004506Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004513Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004520Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004537Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004322Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004339Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004346Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004353Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004360Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004377Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004384Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004391Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004325Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004332Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004349Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004356Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004363Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004370Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004387Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004394Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00194613045883MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613115708MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613116101MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613116118MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
0066641611231980000 Series Reusable General and Rigid Cleaning BrushPrimed Instruments IncGEC2025-06-13