FDA.report

Lens Loop

Primary DI
00841668118917
Brand
Lens Loop
Company
KATENA PRODUCTS, INC.
Model
08-04306
Catalog number
08-04306
Device description
Lewis Lens Loop, Smooth 5.5x8mm
Published
2022-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JYQLOOP, WIRE

Product Code Classifications

CodeDeviceSpecialtyClass
JYQLoop, WireEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841668118917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668118917008416681189178416681189170841668118917

GMDN Terms

TermDefinition
Lens loop, reusableA hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device.

Device Sizes

TypeValueUnit
Length8Millimeter
Width5.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags

DUNS number
085668598
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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