FDA.reportPublic FDA data

GluOn-IF

Primary DI
08800104099700
Brand
GluOn-IF
Company
GS Medical Co., Ltd.
Model
GS136-4005
Catalog number
GS136-4005
Device description
Rasp, 12x14x5mm 0°
Published
2023-02-20
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
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800104099700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800104099700088001040997008800104099700

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

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
08809695601903AnyPlus®GS138-5800GS138-58002026-04-21
08809974806043PYXIS 3D Titanium Cage SystemGS132-3210PGS132-3210P2025-10-14
08809974806050PYXIS 3D Titanium Cage SystemGS132-3212PGS132-3212P2025-10-14
08809974806074PYXIS 3D Titanium Cage SystemGS132-3214PGS132-3214P2025-10-14
08809974806128PYXIS 3D Titanium Cage SystemGS132-3610PGS132-3610P2025-10-14
08809974806135PYXIS 3D Titanium Cage SystemGS132-3612PGS132-3612P2025-10-14
08809974806159PYXIS 3D Titanium Cage SystemGS132-3614PGS132-3614P2025-10-14
08809974806890PYXIS 3D Titanium Cage SystemGS132-6610PGS132-6610P2025-10-14
08809974806906PYXIS 3D Titanium Cage SystemGS132-6612PGS132-6612P2025-10-14
08809974806920PYXIS 3D Titanium Cage SystemGS132-6614PGS132-6614P2025-10-14
08800322752043AnyPlus®GS136-3500GS136-35002026-01-28
08800322752067QUASAR Standalone ACIF SystemGS136-9661GS136-96612026-01-28
08800322752074QUASAR Standalone ACIF SystemGS136-9662GS136-96622026-01-28
08800322752081QUASAR Standalone ACIF SystemGS136-9668GS136-96682026-01-28
08800322752098AnyPlus®GS136-3311GS136-33112026-01-28
08806162109351AnyPlus®GS136-1410GS136-14102026-01-28
08806162109382AnyPlus®GS136-1800GS136-18002026-01-28
08806162109399AnyPlus®GS136-1801GS136-18012026-01-28
08809695589973PYXIS 3D Titanium Cervical Cage, CloseGS110-0981GS110-09812026-01-28
08809695601859AnyPlus®GS138-5520GS138-55202026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200103201ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103225ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103232ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103249ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103256ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103263ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200148431CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148448CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148455CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148462CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148479CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148486CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148493CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148509CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148516CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148523CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148530CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148547CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148554CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148561CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148578CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148585CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148592CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148608CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
00199150082780Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082797Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082803Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082810Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082827Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082834Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04