FDA.report

Alcon

Primary DI
10380657402585
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065740258
Device description
Pre-Bent Pick Fiber Optic, Regular Tip, 2.1m
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

Contact Domains

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
10380657402585PackageGS110In Commercial Distribution
00380657402588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065740258510380657402585
00380657402588003806574025883806574025880380657402588

GMDN Terms

TermDefinition
Fibreoptic operating light systemA system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.

Device Sizes

TypeValueUnit
Length2.1Meter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags

DUNS number
008018525
Device count
1
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
true
Sterilization required before use
false

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