FDA.reportPublic FDA data

Needle aspiration and injection

Primary DI
00841668124680
Brand
Needle aspiration and injection
Company
KATENA PRODUCTS, INC.
Model
K20-3023
Catalog number
K20-3023
Device description
PERIBULBAR NEEDLE 25GA 32MM
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

Contact Domains#

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
00841668113622PrimaryGS10
00841668124680Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668113622008416681136228416681136220841668113622
00841668124680008416681246808416681246800841668124680

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length32Millimeter
Needle Gauge25Gauge

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

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Primary DI, Brand, Company table
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08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
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08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
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