FDA.reportPublic FDA data

ACE

Primary DI
00614950031191
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
4811012
Catalog number
4811012
Device description
"ADAPTER 1/4"" FEMALE NDT/EMPEAS"
Published
2023-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQGADAPTOR, HOLDER, SYRINGE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950031191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950031191006149500311916149500311910614950031191

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100regulatoryandquality@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Premarket exempt
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
06974405095074CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095173CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095180CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097290CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097306CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097313CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097320CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097559CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
00854073007103VIVI CAP SMARTTempramedIQG2025-12-09
00854073007127VIVI MEDTempramedIQG2025-12-09
00187207000467SealSafeAndwin ScientificIQG2025-08-14
00187207000474SealSafeAndwin ScientificIQG2025-08-14
00187207000481SealSafeAndwin ScientificIQG2025-08-14
00187207000498SealSafeAndwin ScientificIQG2025-08-14
00187207000504SealSafeAndwin ScientificIQG2025-08-14
00187207000511SealSafeAndwin ScientificIQG2025-08-14
00817771028849Celling Cardio Application KitCelling BiosciencesIQG2025-04-11
00817771029600Celling Application KitCelling BiosciencesIQG2025-04-11
00860425001620Certa Dose PALS Syringe Holder CD Acquisitions, LLCIQG2025-03-03
00614950030163ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031320ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00850003042305Extremity CareExtremity CareIQG2023-03-30
00854073007097VIVI EPITempramedIQG2022-09-01
00612479259966McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
00612479259973McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
08054083008172AbbVie Lightweight Vest XSABBVIE INC.IQG2021-10-19
08054083008189AbbVie Lightweight Vest SABBVIE INC.IQG2021-10-19
08054083008196AbbVie Lightweight Vest MABBVIE INC.IQG2021-10-19
08054083008202AbbVie Lightweight Vest LABBVIE INC.IQG2021-10-19
08054083008219AbbVie Lightweight Vest XLABBVIE INC.IQG2021-10-19