FDA.reportPublic FDA data

ClickClean™

Primary DI
04719872920120
Brand
ClickClean™
Company
MEDEON BIODESIGN, INC.
Model
UL330
Catalog number
UL330
Device description
The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
Published
2018-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872920137PackageGS11In Commercial Distribution
04719872920144PackageGS112In Commercial Distribution
04719872920199PackageGS11In Commercial Distribution
04719872920205PackageGS112In Commercial Distribution
04719872920311PackageGS110In Commercial Distribution
04719872920120PreviousGS10
04719872920182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872920137047198729201374719872920137
04719872920144047198729201444719872920144
04719872920199047198729201994719872920199
04719872920205047198729202054719872920205
04719872920311047198729203114719872920311
04719872920120047198729201204719872920120
04719872920182047198729201824719872920182

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope lens cleaner, gas/fluid, single-useA sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656078460
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872920359Cross-Seal0020022022-02-01
04719872920380Cross-Seal0020022022-02-01
04719872920328AbCloseM12 Rev.V24M122021-04-27
04719872920014MedeonM12M122017-01-16
04719872920274ClickClean™ S330-SPS330-SP2020-05-15
04719872920281ClickClean™ S330-SPS330-SP2020-05-15
04719872920151ClickClean™ UL030UL0302019-05-03
04719872920182ClickClean™ UL330UL3302019-05-03
04719872920243ClickClean™ US030-SOUS030-SO2020-03-04
04719872920250ClickClean™ US030-SOUS030-SO2020-03-04
04719872920038ClickClean™ L0322017-07-31
04719872920090ClickClean™ UL030UL0302018-11-20
04719872920045ClickClean™ L0322017-07-31
04719872920113ClickClean™ UL030UL0302018-11-20
04719872920144ClickClean™ UL330UL3302018-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18