FDA.report

Ace Medical

Primary DI
00840217906418
Brand
Ace Medical
Company
Ebner Medical
Model
AA9814035
Catalog number
AA9814035
Device description
Infusion Needle 8 hole Liposuction Cannula, 35cm x 4mm, Luer Lock
Published
2022-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840217906418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217906418008402179064188402179064180840217906418

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Device Sizes

TypeValueUnit
Length35Centimeter
Outer Diameter4Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8008220314info@acemedicalco.com

Regulatory Flags

DUNS number
106135367
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
00840217908603Ace Medical CompanyACEBAY07-20TCACEBAY07-20TC2024-01-16
00840217908610Ace Medical CompanyACEDET08-30SACEDET08-30S2024-01-16
00840217908504Wiggins Medical52-731-01B52-731-01B2024-01-05
00840217908511Wiggins Medical52-731-02EB52-731-02EB2024-01-05
00840217908528Wiggins Medical52-731-03EB52-731-03EB2024-01-05
00840217908535Wiggins Medical52-731-04EB52-731-04EB2024-01-05
00840217908542Wiggins Medical52-731-05EB52-731-05EB2024-01-05
00840217908481Ace Medical AA9772020AA97720202023-12-26
00840217908498Ace Medical AA9772030AA97720302023-12-26
00840217907941ACE MedicalAA9781230AA97812302023-12-16
00840217908009Ace Medical CoAA9824023AA98240232023-07-13
00840217908474Wiggins Medical52-741-01B2023-11-09
00840217908443Wiggins Medical52-742-02SPFB2023-11-03
00840217908436Ace Medical CompanyECA-C0012023-10-25
00840217908399Ace Medical CompanyCNA-15L202023-10-23
00840217908405Ace Medical CompanyCMI-20L252023-10-23
00840217908412Ace Medical CompanyECA-C0282023-10-23
00840217908429Ace Medical CompanyECA-C0292023-10-23
00840217908382Ace Medical CoEE7033530V2023-09-29
00840217908368Ace Medical CompanyAA66620902023-09-01

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