FDA.reportPublic FDA data

AnyPlus®

Primary DI
08806395404575
Brand
AnyPlus®
Company
GS Medical Co., Ltd.
Model
GS114-0210
Catalog number
GS114-0210
Device description
Targeting Needle
Published
2020-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806395404575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806395404575088063954045758806395404575

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800322709924VEGA Cervical Screw SystemGTI0108-0003GTI0108-00032026-09-22
08800322709993VEGA Cervical Screw SystemGS128-1600GS128-16002026-09-22
08800322719015VEGA Cervical Screw SystemGS128-0700GS128-07002026-09-22
08800322719022VEGA Cervical Screw SystemGS128-1730GS128-17302026-09-22
08800322759639VEGA Cervical Screw SystemGS128-1010GS128-10102026-09-22
08800322759646VEGA Cervical Screw SystemGS128-1011GS128-10112026-09-22
08800322759653VEGA Cervical Screw SystemGS128-1012GS128-10122026-09-22
08800322759660VEGA Cervical Screw SystemGS128-1013GS128-10132026-09-22
08800322759677VEGA Cervical Screw SystemGS128-1014GS128-10142026-09-22
08800322759684VEGA Cervical Screw SystemGS128-1560GS128-15602026-09-22
08800322759691VEGA Cervical Screw SystemGS128-9000GS128-90002026-09-22
08800322759707VEGA Cervical Screw SystemGS128-9100GS128-91002026-09-22
08800322759714VEGA Cervical Screw SystemGS128-9110GS128-91102026-09-22
08809885759667VEGA Cervical Screw SystemGS128-9011GS128-90112026-09-22
08809885759674VEGA Cervical Screw SystemGS128-9012GS128-90122026-09-22
08809885759797VEGA Cervical Screw SystemGS128-9015GS128-90152026-09-22
08809974779408VEGA Cervical Screw SystemGS128-0200GS128-02002026-09-22
08809974779415VEGA Cervical Screw SystemGS128-0300GS128-03002026-09-22
08809974779422VEGA Cervical Screw SystemGS128-0310GS128-03102026-09-22
08809974779439VEGA Cervical Screw SystemGS128-0320GS128-03202026-09-22

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Primary DI, Brand, Company table
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