FDA.report

Needle aspiration and injection

Primary DI
00841668124697
Brand
Needle aspiration and injection
Company
KATENA PRODUCTS, INC.
Model
K20-3030
Catalog number
K20-3030
Device description
RETROBULBAR NEEDLE 25GA 38MM
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841668113639PrimaryGS10
00841668124697Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668113639008416681136398416681136390841668113639
00841668124697008416681246978416681246970841668124697

GMDN Terms

TermDefinition
Ophthalmic needle, single-useA slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.

Device Sizes

TypeValueUnit
Length38Millimeter
Needle Gauge25Gauge

Sterilization Methods

Method
Radiation Sterilization

Contacts

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

Regulatory Flags

DUNS number
085668598
Device count
10
DM exempt
true
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
true

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00841668146101BLINK60-500960-50092026-03-23
00841668146118BLINK60-502560-50252026-03-23
00841668146125BLINK60-502660-50262026-03-23
00841668146132BLINK60-503060-50302026-03-23

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MHC18018250EasyTouchMHC MEDICAL PRODUCTS, LLCGAA2026-03-17
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00810235030884US Rigid Injection Needle with Huber PointMERZ NORTH AMERICA, INC.GAA2026-03-05
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50198956310047CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-26
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