FDA.reportPublic FDA data

ACE

Primary DI
00614950012619
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
00320118
Catalog number
00320118
Device description
HANDPIECE HOLDER-RECEPTACLE AND FEMALE BRACKET COMPLETE L/F
Published
2019-10-13
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
HXKHOLDER, NEEDLE; ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950012619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950012619006149500126196149500126190614950012619

GMDN Terms#

Term, Definition table
TermDefinition
Medical device storage mountA permanently-fixed structure upon which a medical device (not included) is designed to be mounted for storage purposes only; the device is not intended to be operated whilst mounted to this device. It is commonly wall-mounted and may be available in a variety of designs (e.g., wall bracket), may be dedicated to a specific type of device, or non-dedicated; it is not a shelf.

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(508)588-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
Premarket exempt
true
Lot or batch
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
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
04052536007899neon3Ulrich GmbH & Co. KGHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488153Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488139Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111488160Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111062698Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-11
10649111062957Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-10
10649111063268Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111063541Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111487798Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111487835Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111063879Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-28
10649111487897Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-28
10649111064579Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111064791Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111065439Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111487828Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111065644Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111066344Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111488054Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111077661Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-21