FDA.reportPublic FDA data

Eclipse Hypodermic Needle - 18G

Primary DI
00853602008604
Brand
Eclipse Hypodermic Needle - 18G
Company
ECLIPSE
Model
50PRP2500-N18gx25mm
Device description
"Eclipse 18 Gauge Venting Needle - 18G x 1""; sterilized and individually packaged for single patient use. Venting needle is a component within the Eclipse PRP 22mL Patient Kit."
Published
2022-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172938000Disposable Sterile NeedleJiangsu Caina Medical Co.,Ltd2018-06-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853602008604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853602008604008536020086048536020086040853602008604

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-759-6876info@eclipsemed.com

Regulatory Flags#

DUNS number
969752364
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853602008185Eclipse MicroPen EliteMP1001-IISilverMP1001-IISilver2018-10-04
00853602008390Eclipse EVO Microneedling Cartridge50EVO2000-01050EVO2000-0102022-01-11
00853602008598Eclipse MicroPen EVO50EVO1000-01050EVO1000-0102022-01-11
00853602008406Eclipse MicroPen Elite Turbo Safety CartridgeMPE1002MS-KitMPE1002MS-Kit2019-05-03
00853602008192Eclipse Cosmetic Applicator KitMP1002-CA-K12GFMP1002-CA-K12GF2018-10-04
00853602008208Eclipse Cosmetic Applicator KitMP1002-CA-K12HAMP1002-CA-K12HA2018-10-04
00853602008215Eclipse Cosmetic Applicator KitMP1002-CA-K1GFMP1002-CA-K1GF2018-10-04
00853602008222Eclipse Cosmetic Applicator KitMP1002-CA-K1HAMP1002-CA-K1HA2018-10-04
00853602008239Eclipse MicroPen EliteMP1002-II-K18CANMP1002-II-K18CAN2018-10-04
00853602008246Eclipse Cosmetic Applicator KitCA-100-00-01CA-100-00-012018-10-04
00853602008253Eclipse Cosmetic Applicator KitCA-100-00-02CA-100-00-022018-10-04
00853602008260Eclipse Cosmetic Applicator KitMP1002-CA-K12GF-SMP1002-CA-K12GF-S2018-10-04
00853602008338Eclipse MicroPen EliteMP1002-II-K12HAMP1002-II-K12HA2018-10-04
00853602008345Eclipse MicroPen EliteMP1002-II-K12GFMP1002-II-K12GF2018-10-04
00853602008352Eclipse MicroPen EliteMP1002-II-12MP1002-II-122018-10-04
00853602008369Eclipse MicroPen EliteMP1002-II-K12MP1002-II-K122018-10-04
00853602008376Eclipse MicroPen EliteMP1002-CA-K12HA-SMP1002-CA-K12HA-S2018-10-04
10853602008397Eclipse EVO Microneedling Cartridge50EVO2000-01050EVO2000-0102022-01-11
00853602008611Eclipse Hypodermic Needle - 30G50PRP2500-N30gx13mm50PRP2500-N30gx13mm2022-01-11
00853602008079Eclipse PRP HC PRP2000PRP20002018-10-04

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