FDA.reportPublic FDA data

Rocoto

Primary DI
00860015454751
Brand
Rocoto
Company
Rocoto Inc.
Model
SL11 device Sterilizable Cover - AMN_ASM_1030
Published
2026-02-26
Public version status
New
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
00860015454751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015454751008600154547518600154547510860015454751

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
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
00860014100659AmimonSL11 Sterilizable Cover - AMN_ASM_1030AMN_ASM_10302025-06-24
00860014100666AmimonMD52 Tx device - MDWL2_B1P1TXMDWL2_B1P1TX2025-06-24
00860014100673AmimonMD52 Rx device - MDWL2_B3P1RXMDWL2_B3P1RX2025-06-24
00860014100680AmimonHM11 Device - MDWL1_HM11MDWL1_HM112025-06-24

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Primary DI, Brand, Company table
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05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
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
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
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09