FDA.reportPublic FDA data

Amimon

Primary DI
00860014100659
Brand
Amimon
Company
Rocoto Inc.
Model
SL11 Sterilizable Cover - AMN_ASM_1030
Catalog number
AMN_ASM_1030
Device description
SL11 Sterilizable Cover
Published
2025-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860014100659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014100659008600141006598600141006590860014100659

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
960475866
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015454706RocotoMD62 Tx Device - MDWL2_B1J1TX2026-02-26
00860015454713RocotoMD62 Rx Device - MDWL2_B1J1RX2026-02-26
00860015454720RocotoMD11 Tx device - MDWL1_C1N1TX2026-02-26
00860015454737RocotoMD11 Rx device - MDWL1_B1J1RX2026-02-26
00860015454744RocotoSL11 device - Wireless Camera - MDMP1_SL11_1STE122026-02-26
00860015454751RocotoSL11 device Sterilizable Cover - AMN_ASM_10302026-02-26
00860015454768RocotoMD52 Tx - MDWL2_B1P1TX2026-02-26
00860015454775RocotoMD52 Rx - MDWL2_B3P1RX2026-02-26
00860015454782RocotoHM11 Device - MDWL1_HM112026-02-26
00860014100604AmimonMD62 Tx device - MDWL2_B1J1TXMDWL2_B1J1TX2025-06-24
00860014100611AmimonMD62 Rx device - MDWL2_B1J1RX MDWL2_B1J1RX2025-06-24
00860014100628AmimonMD11 Tx device - MDWL1_C1N1TXMDWL1_C1N1TX2025-06-24
00860014100635AmimonMD11 Rx device - MDWL1_B1N1RXMDWL1_B1N1RX2025-06-24
00860014100642AmimonSL11 device - Wireless Camera - MDMP1_SL11_1STE12MDMP1_SL11_1STE122025-06-24
00860014100666AmimonMD52 Tx device - MDWL2_B1P1TXMDWL2_B1P1TX2025-06-24
00860014100673AmimonMD52 Rx device - MDWL2_B3P1RXMDWL2_B3P1RX2025-06-24
00860014100680AmimonHM11 Device - MDWL1_HM11MDWL1_HM112025-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2026-05-15
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2025-02-28
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2024-06-11
06932503563703eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2024-02-09
06932503563765eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2024-02-09
14714127861392AESCULAPAesculap AGKQM2023-11-05