FDA.report

27ga Awh Brilliant Chandelier, 19ga Needle Connector

Primary DI
00840096211481
Brand
27ga Awh Brilliant Chandelier, 19ga Needle Connector
Company
KATALYST SURGICAL LLC
Model
V2105-27R
Device description
27ga Awh Brilliant Chandelier, 19ga Needle Connector
Published
2020-03-24
Public version status
New
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

Product Codes

CodeName
MPAEndoilluminator

Product Code Classifications

CodeDeviceSpecialtyClass
MPAEndoilluminatorGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840096211488PrimaryGS10
00840096211481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084009621148810840096211488
00840096211481008400962114818400962114810840096211481

GMDN Terms

TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007883297
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
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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