FDA.reportPublic FDA data

ACE

Primary DI
00614950016488
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
9800035
Catalog number
9800035
Device description
SYRINGE GRAFT DELIVERY CURVED W/FUNNEL SS 3.5MM OPENING HOLDS APPROX 1.6CC OF MATERIAL
Published
2019-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950016488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950016488006149500164886149500164880614950016488

GMDN Terms#

Term, Definition table
TermDefinition
Bone grafting cannulaA rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950025510ACE003293700329372019-10-24
00614950025558ACE080000208000022019-10-24
00614950025565ACE080000308000032019-10-24
00614950025572ACE080001108000112019-10-24
00614950013425ACE003105900310592019-10-16
00614950031207ACE484200248420022023-12-05
00614950031214ACE484200348420032023-12-05
00614950030149ACE20982511209825112023-12-05
00614950030927ACE45450201454502012023-12-05
00614950012831ACE90440018S90440018S2019-10-13
00614950012848ACE90440018ST90440018ST2019-10-13
00614950026272ACE90250018902500182019-10-13
00614950026289ACE90250023902500232019-10-13
00614950026296ACE90440018904400182019-10-13
00614950026302ACE90440023904400232019-10-13
00614950026319ACE90440023S90440023S2019-10-13
00614950026326ACE90440023ST90440023ST2019-10-13
00614950026333ACE90500018905000182019-10-13
00614950026340ACE90500018S90500018S2019-10-13
00614950026357ACE90500023905000232019-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71040TBS BASICSACME ENTERPRISE.EIC2026-05-22
00371347023466Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
00371347023473Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
G1493807003TBS DentalACME ENTERPRISE.EIC2026-03-02
00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850440008339IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008346IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008353IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008360IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008377IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008384IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008391ES Cap TipsEngineered Endodontics, LLCEIC2026-01-02
00850440008513ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008520ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008537ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008575JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
008504400086433DPD Paste Delivery TipEngineered Endodontics, LLCEIC2026-01-02
00850440008650Capillary Tip - PremiumEngineered Endodontics, LLCEIC2026-01-02
00850440008667IrriGator Flex TipEngineered Endodontics, LLCEIC2026-01-02
00841336109438Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIC2025-11-11
00810118106439NuSmile NuNamel Pit & Fissure Sealant Brush TipNUSMILE, LTD.EIC2025-07-24
00810118106446NuSmile NuNamel Pit & Fissure Sealant Brush TipNUSMILE, LTD.EIC2025-07-24
00810118106453NuSmile NuNamel Pit & Fissure Sealant Brush TipNUSMILE, LTD.EIC2025-07-24
00810118106521Avalon Biomed Clear Flex Tips - 4 PackNUSMILE, LTD.EIC2025-07-15
00810118106538Avalon Biomed Clear Flex Tips - 20 PackNUSMILE, LTD.EIC2025-07-15
00810118106545Avalon Biomed Clear Flex Tips - 40 PackNUSMILE, LTD.EIC2025-07-15
00883205033123NaviTip 29G SideportULTRADENT PRODUCTS, INC.EIC2025-03-11