FDA.reportPublic FDA data

CRYSTALVIEW

Primary DI
10845854850381
Brand
CRYSTALVIEW
Company
Conmed Corporation
Model
CV4000
Catalog number
CV4000
Device description
CrystalView™ Pro Irrigation Console
Published
2020-04-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182882000CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation2018-11-14HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845854850381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084585485038110845854850381

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly designed to provide controlled distention and irrigation (expansion by pressure and continual flushing) of the tissue and space around a joint where arthroscopy is being performed (e.g., the knee or shoulder joint). This is achieved by filling the cavity with a sterile fluid that is pumped into the wound by the system's pump(s) and distends the tissue around the site to improve visualization and enlarge the surgical field. Suction may also be applied by the system to assist in the removal of the surgically-resected bone, cartilage, and other tissue/debris from the site.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
1
Serial number
true
Manufacturing date on label
true

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30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
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10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
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