FDA.reportPublic FDA data

ACE

Primary DI
00614950031252
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
6828023
Catalog number
6828023
Device description
REPLACEMENT BLACK ROLL FOR HANDLE OF BONE MILL #688275
Published
2023-12-05
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
LYSBone mill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYSBone MillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950031252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950031252006149500312526149500312520614950031252

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
00614950007547OUSIA bioXENOUSM2OUSM22015-10-24
00614950007554OUSIA bioXENOUSM3OUSM32015-10-24
00614950007561OUSIA bioXENOUSM4OUSM42015-10-24
00614950007578OUSIA bioXENOUSM5OUSM52015-10-24
00614950007585OUSIA bioXENOUSM6OUSM62015-10-24
00614950007721OUSIA bioXENOUSM1OUSM12015-10-24
00614950027910Collagen Matrix509400150940012023-06-16
00614950027927Collagen Matrix509400250940022023-06-16
00614950027934MinerOss® XBH0034BH00342022-10-27
00614950027941MinerOss® XBH0035BH00352022-10-27
00614950027958MinerOss® XBH0036BH00362022-10-27
00614950027965MinerOss® XBH0037BH00372022-10-27
00614950027972MinerOss® XBH0038BH00382022-10-27
00614950027989MinerOss® XBH0039BH00392022-10-27
00614950027996MinerOss® XBH0044BH00442022-10-27
00614950028009MinerOss® XBH0045BH00452022-10-27
00614950028016MinerOss® XBH0046BH00462022-10-27
00614950028023MinerOss® XBH0047BH00472022-10-27
00614950028030MinerOss® XBH0052BH00522022-10-27
00614950028047MinerOss® XBH0053BH00532022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791062720DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDLYS2026-08-22
B504BM54007010000StrykerProvisionLYS2024-09-16
00889024675346Z1™ Hip SystemZimmer, Inc.LYS2024-09-09
00889024675353Z1™ Hip SystemZimmer, Inc.LYS2024-09-09
00889024675360Z1™ Hip SystemZimmer, Inc.LYS2024-09-09
B504BMBM2100MedtronicProvisionLYS2024-06-11
04047844121368DIPLOMATSIGNUS Medizintechnik GmbHLYS2024-06-05
00842517106253Karl SchumacherKarl Schumacher Dental, LLCLYS2024-02-27
10603295516378NADEPUY ORTHOPAEDICS, INC.LYS2024-01-15
00888118142924BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142931BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142948BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142955BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142962BONE MILLKLS-Martin L.P.LYS2023-11-22
00841336103399Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCLYS2023-08-10
00841336103504Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCLYS2023-08-10
00888118142597BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142603BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142610BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142627BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142634BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142641BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142658BONE MILLKLS-Martin L.P.LYS2023-07-04
00190776264055AvalignAvalign Technologies, Inc.LYS2023-06-23
08720254007816Sterilization tray NBMSpierings Orthopaedics B.V.LYS2023-06-20
08720254007823HousingSpierings Orthopaedics B.V.LYS2023-06-20
08720254007830Push BlockSpierings Orthopaedics B.V.LYS2023-06-20
08720254007847HandleSpierings Orthopaedics B.V.LYS2023-06-20
08720254007854Screw nutSpierings Orthopaedics B.V.LYS2023-06-20
08720254007861Milling Drum Extra Extra Extra FineSpierings Orthopaedics B.V.LYS2023-06-20