FDA.reportPublic FDA data

ACU-NEEDLE

Primary DI
00814105020388
Brand
ACU-NEEDLE
Company
ACUDERM, INC.
Model
0N2235
Device description
"22 standard gauge 2 3/4"" Liposuction/injection needle, metal hub, 3"", for suction and injection of fat, blunt or tri-beveled, non-sterile "
Published
2020-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K874024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874024000ACU-MICRO-NEEDLEAcuderm, Inc.1987-11-23FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814105020388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814105020388008141050203888141050203880814105020388

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-733-6935cust-service@acuderm.com

Regulatory Flags#

DUNS number
071426803
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814105020005Acu-Dispo-CuretteR012020-09-22
00814105020012Acu-Dispo-CuretteR022020-09-22
00814105020029Acu-Dispo-CuretteR032020-09-22
00814105020036Acu-Dispo-CuretteR042020-09-22
00814105020043Acu-Dispo-CuretteR052020-09-22
00814105020050Acu-Dispo-CuretteR072020-09-22
00814105020883Acu-PunchP12020-09-22
00814105020890Acu-PunchP1.52020-09-22
00814105020906Acu-PunchP22020-09-22
00814105020913Acu-PunchP2.52020-09-22
00814105020920Acu-PunchP32020-09-22
00814105020937Acu-PunchP3.52020-09-22
00814105020944Acu-PunchP42020-09-22
00814105020951Acu-PunchP4.52020-09-22
00814105020968Acu-PunchP52020-09-22
00814105020975Acu-PunchP62020-09-22
00814105020982Acu-PunchP72020-09-22
00814105020999Acu-PunchP82020-09-22
00814105021002Acu-PunchP102020-09-22
00814105021019Acu-PunchP122020-09-22

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