FDA.reportPublic FDA data

Anesthesia Needle - Atkinson

Primary DI
00813465010022
Brand
Anesthesia Needle - Atkinson
Company
HURRICANE MEDICAL INC
Model
1025
Catalog number
1025
Device description
For administering local anesthetics 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
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813465010022PrimaryGS10
10813465010029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813465010022008134650100228134650100220813465010022
1081346501002910813465010029

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length32Millimeter
Needle Gauge25Gauge

Sterilization Methods#

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

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
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08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592475WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592499WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592512WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592529WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592550WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592567WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08