FDA.reportPublic FDA data

Sub-Tenon's Cannula

Primary DI
00813465010114
Brand
Sub-Tenon's Cannula
Company
HURRICANE MEDICAL INC
Model
1330
Catalog number
1330
Device description
For administering local anesthetic agents prior to ophthalmic surgery.
Published
2020-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00813465010114PrimaryGS10
10813465010111Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813465010114008134650101148134650101140813465010114
1081346501011110813465010111

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22Millimeter
Needle Gauge30Gauge

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Radiation Sterilization""]"
Ethylene Oxide;Radiation Sterilization

Regulatory Flags#

DUNS number
093377724
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813465012071Surgical Glide920192012020-05-05
00813465012101IOL Glide - Sheets920492042020-05-05
00813465011135IOL Manipulator - Lester680168012020-05-08
00813465011142IOL Manipulator - Sinskey680268022020-05-08
00813465011166IOL Manipulator - Sinskey680468042020-05-08
00813465011173Nucleus Chopper - P. Koch681068102020-05-08
00813465011180Nucleus Chopper - Beckingsale681168112020-05-08
10813465011132IOL Manipulator - Lester680168012020-05-08
10813465011149IOL Manipulator - Sinskey680268022020-05-08
10813465011163IOL Manipulator - Sinskey680468042020-05-08
10813465011170Nucleus Chopper - P. Koch681068102020-05-08
10813465011187Nucleus Chopper - Beckingsale681168112020-05-08
00813465011197Silicone Tubing700270022020-05-07
00813465011319Marker Pad - Gentian Violet730373032020-05-07
00813465011326Marker Pad - Methylene Blue730473042020-05-07
00813465011432Dual Tip Marker Pen - Gentian Violet731973192020-05-07
00813465011449Dual Tip Marker Pen - Methylene Blue732073202020-05-07
00813465012125.20 Micron Filter930193012020-05-07
00813465012149Male to Male Luer Connector930393032020-05-07
10813465011194Silicone Tubing700270022020-05-07

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