FDA.reportPublic FDA data

Amimon

Primary DI
00817157020801
Brand
Amimon
Company
AMIMON LTD
Model
SL11 device Sterilizable Cover - AMN_KIT_1002
Published
2023-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817157020801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817157020801008171570208018171570208010817157020801

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, reusableA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534112800
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817157020832AmimonHM11 Device - MDWL1_HM112025-04-03
00817157020818AmimonMD52 Tx - MDWL2_B1P1TX2024-05-29
00817157020825AmimonMD52 Rx - MDWL2_B3P1RX2024-05-29
00817157020795AmimonSL11 device - Wireless Camera - MDMP1_SL11_1STE122023-07-26
00817157020764AmimonMD11 System - MDWL1_C1N1TX2023-07-07
00817157020771AmimonMD11 System - MDWL2_B1N1RX2023-07-07
00817157020740AmimonMD62 System - MDWL2_B1J1TX2023-05-05
00817157020757AmimonMD62 System - MDWL2_B1J1RX2023-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
00818089022437RadianceNds Surgical Imaging LLCKQM2026-02-10
08800025400692EZ SHOT SEGOOD DOCTORS CO., LTD.KQM2026-01-15
05415334050020BarcoBarco NVKQM2025-12-22
05415334050013BarcoBarco NVKQM2025-12-01
00819761023032Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-25
00819761023049Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-24
00860012447107EclipseInnovations Lightx IncKQM2025-11-12
00724995245061HexaVueBLACK DIAMOND VIDEO, INC.KQM2025-10-17
00810000890712FSNFORESEESON CUSTOM DISPLAYS, INC.KQM2025-09-15
04548736170698SONYSONY CORPORATIONKQM2025-09-12
04548736170711SONYSONY CORPORATIONKQM2025-09-12
07613327661194In-Light CameraSTRYKER COMMUNICATIONS INC.KQM2025-08-27
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
04995047069867CuratOREIZO CORPORATIONKQM2025-07-18
04995047070320CuratOREIZO CORPORATIONKQM2025-07-18
00840183530402BR Surgical, LLCBR Surgical, LLCKQM2025-07-16
20618125114669SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170728SONYSONY CORPORATIONKQM2025-07-08
04548736170742SONYSONY CORPORATIONKQM2025-07-08
06972039971085MOPTIMShenzhen CERTAINN Technology Co., Ltd.KQM2025-06-30
00860014100642AmimonRocoto Inc.KQM2025-06-24
00860014100659AmimonRocoto Inc.KQM2025-06-24
05415334051133SterisBarco NVKQM2025-06-05
04548736167117SONYSONY CORPORATIONKQM2025-05-30
04548736167124SONYSONY CORPORATIONKQM2025-05-30