FDA.reportPublic FDA data

27ga Reusable Maeno-Awh Super Manipulator

Primary DI
00840096205282
Brand
27ga Reusable Maeno-Awh Super Manipulator
Company
KATALYST SURGICAL LLC
Model
V1030-27
Published
2019-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096205282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096205282008400962052828400962052820840096205282

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1081748902630125ga DEX™ Slim Morris ILM ForcepsDVFO4033-25DVFO4033-252020-09-21
1081748902631827ga DEX™ Stiff Slim Morris ILM ForcepsDVFO4033-27DVFO4033-272020-09-21
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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Primary DI, Brand, Company table
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