FDA.report

NA

Primary DI
10653405055624
Brand
NA
Company
Conmed Corporation
Model
CD7570M
Catalog number
CD7570M
Device description
Trocar Procedure Kit, Lap Appy
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653405055624PackageGS110Not in Commercial Distribution
20653405055621PrimaryGS10
00653405055627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340505562410653405055624
2065340505562120653405055621
00653405055627006534050556276534050556270653405055627

GMDN Terms

TermDefinition
Cardiology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter5Millimeter

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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