FDA.reportPublic FDA data

DIPLOMAT

Primary DI
04047844066751
Brand
DIPLOMAT
Company
SIGNUS Medizintechnik GmbH
Model
Guide wire, round/round
Catalog number
AC0125
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
2022-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844066751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844066751040478440667514047844066751

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04047844130957DIPLOMATGuide wire, round/roundAC01602026-10-26
04047844130964DIPLOMATGuide wire, trocar/roundAC01612026-10-26
04047844005668KAINOS+Bone graft substitute, granules 2-3mmK001NT2015-09-24
04047844005675KAINOS+Bone graft substitute, granules 2-3mmK003NT2015-09-24
04047844005682KAINOS+Bone graft substitute, granules 2-3mmK004NT2015-09-24
04047844005699KAINOS+Bone graft substitute, granules 2-3mmK005NT2015-09-24
04047844005705KAINOS+Bone graft substitute, granules 2-3mmK006NT2015-09-24
04047844005712KAINOS+Bone graft substitute, insert for NUBICKNB0413142018-09-20
04047844005729KAINOS+Bone graft substitute, insert for NUBICKNB0513142018-09-20
04047844005736KAINOS+Bone graft substitute, insert for NUBICKNB0613142018-09-20
04047844005743KAINOS+Bone graft substitute, insert for NUBICKNB0713142018-09-20
04047844005750KAINOS+Bone graft substitute, insert for NUBICKNB0813142018-09-20
04047844005996KAINOS+Bone graft substitute, granules 1-2mmKS03NT2015-09-24
04047844006009KAINOS+Bone graft substitute, granules 1-2mmKS06NT2015-09-24
04047844023747KAINOS+Bone graft substitute, granulate 2-3mmK002NT2015-09-24
04047844130971DIPLOMATGuide wire, round/roundAC01622026-08-14
04047844130988DIPLOMATGuide wire, trocar/roundAC01632026-08-14
04047844066768DIPLOMATGuide wire, trocar/roundAC01262025-05-21
04047844042779DIPLOMATGuide wire obturatorAC0003-22022-06-09
04047844129418DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-951202026-07-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
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00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
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