FDA.report

INSTRUMENT

Primary DI
04047844059852
Brand
INSTRUMENT
Company
SIGNUS Medizintechnik GmbH
Model
Rasp, rectangular
Catalog number
SK-0103
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
2025-05-09
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
false

Related Records

Contact Domains

Product Codes

CodeName
HRTStripper, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04047844059852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04047844059852040478440598524047844059852

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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04047844129340COSYRack, screwsCA1245AZ2026-02-11
04047844129357COSYRack, shank screwsCA1735AZ2026-02-11
04047844129364COSYRack, shank screwsCA1740AZ2026-02-11
04047844129371COSYRack, screws angledCA3235AZ2026-02-11
04047844129388COSYRack, screws angledCA3240AZ2026-02-11
04047844129395COSYRack, set screwsCA0140AZ2026-02-11
04047844129401COSYRack, set screws, connectorsCA0150AZ2026-02-11
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04047844122860CYLOX ST 12°Cervical cage integrated, stand alone, angledCYS120615122025-09-11
04047844122877CYLOX ST 12°Cervical cage integrated, stand alone, angledCYS120715122025-09-11
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