FDA.report

Alcon

Primary DI
10380659215015
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065921501
Device description
Ophthalmic Knife 15°
Published
2020-08-18
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

Contact Domains

Product Codes

CodeName
HNNKnife, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380659215015PackageGS16In Commercial Distribution
00380659215018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065921501510380659215015
00380659215018003806592150183806592150180380659215018

GMDN Terms

TermDefinition
Ophthalmic knife, single-useA sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

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
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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