FDA.report

Bausch + Lomb

Primary DI
20757770529210
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
CX6803
Catalog number
CX6803
Device description
23 GA PNEUMATIC HSV CUTTER
Published
2016-09-24
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

Product Codes

CodeName
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20757770529210PrimaryGS10
10757770529213Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2075777052921020757770529210
1075777052921310757770529213

GMDN Terms

TermDefinition
Vitrectomy system micro-cutting unitA sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
196603781
Device count
6
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
false

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