FDA.reportPublic FDA data

ClikRay Size I/O Camera Sleeves fits DexCam 3 - 500/BOX

Primary DI
00856200001763
Brand
ClikRay Size I/O Camera Sleeves fits DexCam 3 - 500/BOX
Company
CLIKTECH LLC
Model
001-763
Catalog number
001-763
Device description
ClikRay Size I/O Camera Sleeves fits DexCam 3 - 500/BOX
Published
2020-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
10856200001760PackageGS120In Commercial Distribution
00856200001763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085620000176010856200001760
00856200001763008562000017638562000017630856200001763

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
044516217
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856200001138ClikRay Size 1 Sensor Cover 34mm/ 500 box001-138001-1382020-12-31
00856200001145ClikRay Size 1+2 Sensor Cover 36mm/ Box 500001-145001-1452020-12-31
00856200001152ClikRay Size 2 Sensor Cover 40mm/ Box 500001-152001-1522020-12-31
00856200001442ClikRay Green Line Universal Large Sensor Cover 40mm/500Box001-442001-4422020-12-31
00856145008001XL-Series Size 1 Anterior BLUE Bite Block 3-Pack008-001008-0012020-12-31
00856145008018XL-Series Size 1 Posterior YELLOW Bite Block 3-Pack008-018008-0182020-12-31
00856145008025XL-Series Size 1 Horizontal Bitewing DK ORANGE Bite Block 3-Pack008-025008-0252020-12-31
00856145008032XL-Series Size 1 Vertical Bitewing DK ORANGE Bite Block 3-Pack008-032008-0322020-12-31
00856145008049XL-Series Size 2 Anterior BLUE Bite Block 3-Pack008-049008-0492020-12-31
00856145008056XL-Series Size 2 Posterior YELLOW Bite Block 3-Pack008-056008-0562020-12-31
00856145008063XL-Series Size 2 Horizontal Bitewing DK ORANGE Bite Block 3-Pack008-063008-0632020-12-31
00856145008070XL-Series Size 2 Vertical Bitewing DK ORANGE Bite Block 3-Pack008-070008-0702020-12-31
00856145008087XL-Series Size 1 ShaRing Starter Kit008-087008-0872020-12-31
00856145008094XL-Series Size 2 ShaRing Starter Kit008-094008-0942020-12-31
00856145008100ClikStik, IRing, IRod, and 8 XL-Series Bite Blocks; Size 1&2008-100008-1002020-12-31
00856145008117ClikStik, IRing, IRod, and 8 Z-Series Bite Blocks; Size 1&2008-117008-1172020-12-31
00856145008124V-Series Size 2 Anterior WHITE Bite Block 3-Pack008-124008-1242020-12-31
00856145008131V-Series Size 2 Posterior WHITE Bite Block 3-Pack008-131008-1312020-12-31
00856145008148V-Series Size 2 Vertical Bitewing WHITE Bite Block 3-Pack008-148008-1482020-12-31
00856145008155V-Series Size 2 Horizontal Bitewing WHITE Bite Block 3-Pack008-155008-1552020-12-31

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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
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04548736155091SONYSONY CORPORATIONKQM2025-09-30
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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