FDA.reportPublic FDA data

ACE

Primary DI
00614950025503
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0032936
Catalog number
0032936
Device description
PROTRACTOR CEPHALOMETRIC L/F *COLD STERILIZE ONLY*
Published
2019-10-24
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
HTHPROTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTHProtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950025503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950025503006149500255036149500255030614950025503

GMDN Terms#

Term, Definition table
TermDefinition
Bone-angle protractorA device intended to be used to measure the angles of bones, e.g., on x-rays or during surgery. It is commonly known as a protractor. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@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
008411321863743P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321863813P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321863983P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321874943P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
08800017285429BENCOX DA Instruments Hip SystemCorentec Co., LtdHTH2024-01-29
G223WRROGPRO0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHTH2022-12-05
00842430108891ScoliometerMIZUHO ORTHOPEDIC SYSTEMS, INC.HTH2019-04-02
00889024038004NAZimmer, Inc.HTH2016-07-27