FDA.report

23ga Diamondless Brush Polisher

Primary DI
00817489020951
Brand
23ga Diamondless Brush Polisher
Company
KATALYST SURGICAL LLC
Model
DV1001-23
Device description
Box of 5, 23ga Diamondless Brush Polisher
Published
2016-08-10
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
MXYCannula,Ophthalmic,Posterior Capsular Polishing,Polyvinyl Acetal

Product Code Classifications

CodeDeviceSpecialtyClass
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817489020951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817489020951008174890209518174890209510817489020951

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). 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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