FDA.report

20ga Dex Tips™ Curved Horizontal Scissors

Primary DI
00817489023488
Brand
20ga Dex Tips™ Curved Horizontal Scissors
Company
KATALYST SURGICAL LLC
Model
CVS5006-20
Device description
Box of 5, 20ga Dex Tips™ Curved Horizontal Scissors
Published
2016-08-11
Public version status
Update
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
HNFScissors, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817489023488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817489023488008174890234888174890234880817489023488

GMDN Terms

TermDefinition
Anterior/posterior segment scissors, single-useAn ophthalmic surgical instrument designed to cut either anterior or posterior segment tissue during eye surgery. It is typically: 1) two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed); or 2) an instrument tip, with cutting blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007883297
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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