FDA.reportPublic FDA data

ACE

Primary DI
00614950016587
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
1000210
Catalog number
1000210
Device description
"CURETTE BONE LUCAS #86 D/E 7"" 18CM"
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
EKTCURETTE, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKTCurette, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950016587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950016587006149500165876149500165870614950016587

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

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
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
00810123209682Adler Instrument CompanyAdler, Inc.EKT2025-12-08
00190776410643MillenniumAvalign Technologies, Inc.EKT2025-09-11
00190776409166MillenniumAvalign Technologies, Inc.EKT2025-08-22
00190776405304MillenniumAvalign Technologies, Inc.EKT2025-07-15
00810123208340Adler Instrument CompanyAdler, Inc.EKT2025-01-27
00614950031405ACEACE SURGICAL SUPPLY CO., INC.EKT2023-12-05
00190776075002AvalignAvalign Technologies, Inc.EKT2023-11-13
00190776075019AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287412AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287429AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287436AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287498AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776351359MILLENNIUMAvalign Technologies, Inc.EKT2023-09-28
00190776372606AvalignAvalign Technologies, Inc.EKT2023-09-28
00810123202362Adler Instrument CompanyAdler, Inc.EKT2023-03-16
00190776363277MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363284MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363291MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363307MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363314MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363321MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363338MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363345MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363352MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363369MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363376MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363383MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363390MillenniumAvalign Technologies, Inc.EKT2023-02-22
14026704803382PILLINGTELEFLEX INCORPORATEDEKT2022-12-08
54026704803397PILLINGTELEFLEX INCORPORATEDEKT2022-12-08