FDA.reportPublic FDA data

CYLOX ST

Primary DI
04047844127988
Brand
CYLOX ST
Company
SIGNUS Medizintechnik GmbH
Model
Drill guide
Catalog number
CZ0003-05
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
2025-05-27
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
HWQPasser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844127988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844127988040478441279884047844127988

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
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
00816101010004Flexor Tendon Sheath Retractor and Suture Retriever / Sheath DilatorTOBY ORTHOPAEDICSHWQ2026-04-22
00190776419998MillenniumAvalign Technologies, Inc.HWQ2026-04-15
00190776420000MillenniumAvalign Technologies, Inc.HWQ2026-04-15
10818674022207Suture passeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2026-04-14
10850067560170LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560187LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560194LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560173LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560180LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560197LaproCloseSurgical Principals, IncHWQ2025-12-11
00842188130243Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130250Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130267Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130212Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130229Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130236Shuttle PinTrimed, INC.HWQ2025-07-08
00840277409935P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409942P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409959P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
10810128461075AC Slider NeedleT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846117425° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846118125° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846119845° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846120445° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846121190° Tight Curve, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461228Crescent, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461235Straight, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
04047844127964CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27
04047844127971CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27
04047844127995CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27