FDA.report

Alcon

Primary DI
10380654418206
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065441820
Device description
Microsurgical Instrument "J" SHAPED HYDRODISSECTOR 25GA
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
HMXCannula, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380654418206PackageGS110In Commercial Distribution
00380654418209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065441820610380654418206
00380654418209003806544182093806544182090380654418209

GMDN Terms

TermDefinition
Exploratory blunt needle, single-useA sterile, slender, hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. 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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