FDA.report

Alcon

Primary DI
10380654259205
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065425920
Device description
Microsurgical Instrument IRR. CYSTITSOME 27GA STRAIGHT-REVERSE CUTTING
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
HNYCystotome

Product Code Classifications

CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380654259205PackageGS110In Commercial Distribution
00380654259208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065425920510380654259205
00380654259208003806542592083806542592080380654259208

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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