FDA.reportPublic FDA data

DIPLOMAT

Primary DI
04047844121368
Brand
DIPLOMAT
Company
SIGNUS Medizintechnik GmbH
Model
Reamer
Catalog number
AC0071-H
Device description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Published
2024-06-05
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
04047844121368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844121368040478441213684047844121368

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04047844129241DIPLOMATThreaded awl cannulated, obturatorAC00882026-05-20
04047844129258DIPLOMATThreaded awl cannulated, obturatorAC00892026-05-20
04047844102596COSYCross connectorCA0155-38048/S2023-03-21
04047844102602COSYCross connectorCA0155-44052/S2023-03-21
04047844098479COSYRetaining nut tulips cross connectorCA0160-002002023-03-15
04047844127063COSYTray, lidCB03AY-LID-12026-04-22
04047844098707COSYOcciput plateCA0005-320562023-03-15
04047844116432COSYObturatorwireCB0101-32023-03-15
04047844116449COSYGuide wire, round/roundCB01442023-03-15
04047844129272INSTRUMENTTray, instrumentsP009AY2026-02-11
04047844129289INSTRUMENTTray, insert, instrumentsP009AZ2026-02-11
04047844129296COSYTray, implantsCA01AY2026-02-11
04047844129302COSYTray, insert, implantsCA01AZ2026-02-11
04047844129319COSYTray, implantsCA02AY2026-02-11
04047844129326COSYRack, screwsCA1235AZ2026-02-11
04047844129333COSYRack, screwsCA1240AZ2026-02-11
04047844129340COSYRack, screwsCA1245AZ2026-02-11
04047844129357COSYRack, shank screwsCA1735AZ2026-02-11
04047844129364COSYRack, shank screwsCA1740AZ2026-02-11
04047844129371COSYRack, screws angledCA3235AZ2026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842517106253Karl SchumacherKarl Schumacher Dental, LLCLYS2024-02-27
10603295516378NADEPUY ORTHOPAEDICS, INC.LYS2024-01-15
00614950031252ACEACE SURGICAL SUPPLY CO., INC.LYS2023-12-05
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
08720254007878Milling Drum Extra Extra FineSpierings Orthopaedics B.V.LYS2023-06-20