FDA.report

Bausch + Lomb

Primary DI
00757770058587
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
BL5223WV
Catalog number
BL5223WV
Device description
TSV 23ga Posterior Vitrectomy Pack with Valves and Wide Field Illuminator
Published
2016-11-08
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
00757770058587PrimaryGS10
20757770058581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770058587007577700585877577700585870757770058587
2075777005858120757770058581

GMDN Terms

TermDefinition
Vitrectomy fluid/gas handling handpiece/cannulaA sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. 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
true
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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00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
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