FDA.report

ClearCam Kelling

Primary DI
B883SZ3005301
Brand
ClearCam Kelling
Company
ClearCam
Model
1
Catalog number
SZ3005301
Device description
ClearCam Kelling, Karl Storz Compatible, 30cm x 05mm x 30 degree, version 1
Published
2020-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B883SZ3005301PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical instrument/endoscope cleaning brush/tool, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081499310
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B883CCSFS0501ClearCam Surefit Spacer1CCsfs05012021-03-01
B883OY3005001ClearCam Kelling1OY30050012020-06-23
B883OY3005301ClearCam Kelling1OY30053012020-06-23
B883SZ3005001ClearCam Kelling1SZ30050012020-06-23
B883SK300530113ClearCam Kelling1SK30053012020-05-05
B883SK300500110ClearCam Kelling1SK30050012020-05-01

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