FDA.report

Single Use Kit

Primary DI
09360506000029
Brand
Single Use Kit
Company
GYDER SURGICAL PTY LTD
Model
GS002
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K243387000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243387000GYDER® Hip SystemGyder Surgical Pty, Ltd.2025-01-29OLO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09360506000029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09360506000029093605060000299360506000029

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other 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 single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
744585548
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
09360506000111Navigation Unit KitGS0042025-09-18
09360506000128Navigation ToolsetGS0052025-09-18

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