FDA.reportPublic FDA data

DIPLOMAT

Primary DI
04047844043585
Brand
DIPLOMAT
Company
SIGNUS Medizintechnik GmbH
Model
Bending iron, in-situ
Catalog number
AC0058
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
2022-06-08
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
HXWBender

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844043585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844043585040478440435854047844043585

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 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
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
04047844129579DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550602026-07-13
04047844129586DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650252026-07-13
04047844129593DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650302026-07-13
04047844129609DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650352026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8034709150ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709160ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709170ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709180ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709190ORTHOMEDORTHO-MED, INC.HXW2026-07-14
008401944958133P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958203P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958373P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958443P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958513P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
08809695601781GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809695630187GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809885726911Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
08809885726928Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
08809885798017Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
10705034576985N/ADEPUY SPINE, LLCHXW2024-12-16
10887587077635NASynthes GmbHHXW2024-08-21
10887587077963NASynthes GmbHHXW2024-08-21
G079C5040000010Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000020Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000030Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
08800089415212INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089417308INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18