FDA.report

VUETIP

Primary DI
30845854061774
Brand
VUETIP
Company
Conmed Corporation
Model
VUETIP10
Catalog number
VUETIP10
Device description
VueTip Trocar Swab Accessory Kit Laparoscopic Solutions
Published
2020-06-01
Public version status
Update
Distribution status
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
30845854061774PackageGS110In Commercial Distribution
00815198012366PreviousGS10
20845854061777PrimaryGS10
00845854061773Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585406177430845854061774
00815198012366008151980123668151980123660815198012366
2084585406177720845854061777
00845854061773008458540617738458540617730845854061773

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature40 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods

Method
Radiation Sterilization

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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