FDA.reportPublic FDA data

Titanium Lid Retractor, 11mm

Primary DI
00840096206562
Brand
Titanium Lid Retractor, 11mm
Company
KATALYST SURGICAL LLC
Model
4453
Device description
Titanium Lid Retractor, 11mm
Published
2020-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096206562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096206562008400962065628400962065620840096206562

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, reusableA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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1081748902714823ga DEX™ Hassan ForcepsDVF4035-23DVF4035-232020-11-01
1081748902716227ga DEX Stiff Hassan ForcepsDVF4035-27DVF4035-272020-11-01
1081748902731523ga Slim DEX™ Hassan ForcepsDVFO4035-23DVFO4035-232020-09-21
1081748902732225ga Slim DEX™ Hassan ForcepsDVFO4035-25DVFO4035-252020-09-21
1081748902733927ga Stiff Slim DEX™ Hassan ForcepsDVFO4035-27DVFO4035-272020-09-21
1081748902735327ga Slim DEX™ Vertical ScissorsDVSO5101-272020-11-01
1081748902739123ga MultiFlex Laser Probe, Iridex CompatibleXLEND23MULTIFLEXAXLEND23MULTIFLEXA2018-11-26
1084009621104423ga Slim DEX™ Super Grip II ForcepsDVFO4036-23DVFO4036-232020-09-21
1084009621110525ga Slim DEX™ Super Grip II ForcepsDVFO4036-25DVFO4036-252020-09-21
1084009621111227ga Stiff Slim DEX™ Super Grip II ForcepsDVFO4036-27DVFO4036-272020-09-21
1084009621117425ga Stiff DEX™ Yoneda Super Grip ForcepsDVF4036-25-SDVF4036-25-S2020-11-01
1084009621289823ga DEX™ EZPeel ForcepsDVF4037-23DVF4037-232020-07-06
1084009621290425ga DEX™ EZPeel ForcepsDVF4037-25DVF4037-252020-07-06
1084009621291127ga DEX™ EZPeel ForcepsDVF4037-27DVF4037-272020-07-06
1084009621292825ga Stiff DEX™ EZPeel ForcepsDVF4037-25-SDVF4037-25-S2020-07-06
1084009621293523ga Slim DEX™ EZPeel ForcepsDVFO4037-23DVFO4037-232020-07-06
1084009621294225ga Slim DEX™ EZPeel ForcepsDVFO4037-25DVFO4037-252020-07-06
1084009621295925ga Slim Stiff DEX™ EZPeel ForcepsDVFO4037-25-SDVFO4037-25-S2020-07-06

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