FDA.reportPublic FDA data

DIPLOMAT

Primary DI
04047844130988
Brand
DIPLOMAT
Company
SIGNUS Medizintechnik GmbH
Model
Guide wire, trocar/round
Catalog number
AC0163
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
2026-08-14
Public version status
New
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
HXIPasser, Wire, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844130988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844130988040478441309884047844130988

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
04047844130971DIPLOMATGuide wire, round/roundAC01622026-08-14
04047844066768DIPLOMATGuide wire, trocar/roundAC01262025-05-21
04047844042779DIPLOMATGuide wire obturatorAC0003-22022-06-09
04047844066751DIPLOMATGuide wire, round/roundAC01252022-06-09
04047844129418DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-951202026-07-13
04047844129425DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450252026-07-13
04047844129432DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450302026-07-13
04047844129449DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450352026-07-13
04047844129456DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450402026-07-13
04047844129463DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450452026-07-13
04047844129470DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450502026-07-13
04047844129487DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450552026-07-13
04047844129494DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450602026-07-13
04047844129500DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550252026-07-13
04047844129517DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550302026-07-13
04047844129524DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550352026-07-13
04047844129531DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550402026-07-13
04047844129548DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550452026-07-13
04047844129555DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550502026-07-13
04047844129562DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550552026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04047844130971DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
10810128464137WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-07-22
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15
00841731138095TITANEX VILEX LLCHXI2026-05-15
00841731142870TITANEX VILEX LLCHXI2026-05-15
00841731142887TITANEX VILEX LLCHXI2026-05-15
00841731146717TITANEXVILEX LLCHXI2026-05-15
00841731146724TITANEXVILEX LLCHXI2026-05-15
00841731146731TITANEXVILEX LLCHXI2026-05-15
00841731147141TITANEX VILEX LLCHXI2026-05-15
00889795152671Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152688Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152695Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
B8034803860ORTHOMEDORTHO-MED, INC.HXI2026-04-16
B8034803880ORTHOMEDORTHO-MED, INC.HXI2026-04-16
00840311246830Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXI2026-03-18
10810128462645Nitinol Loop Passer MEDACTAT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-02-09
00841731134769Hintermann Series VILEX LLCHXI2026-01-16
06974940306369endophixSuzhou Endophix Co., Ltd.HXI2025-12-12
06974940306147endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306154endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306161endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306178endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306185endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306192endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306208endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306215endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306222endophixSuzhou Endophix Co., Ltd.HXI2025-12-05