FDA.reportPublic FDA data

Pulsar

Primary DI
08800104097744
Brand
Pulsar
Company
GS Medical Co., Ltd.
Model
GS133-1883
Catalog number
GS133-1883
Device description
Inserter Fork, 12mm
Published
2022-11-01
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800104097744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800104097744088001040977448800104097744

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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
00199150002139N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00199150002146N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
00822409082155N/AOrtho Development CorporationLXH2026-07-16
00822409082162N/AOrtho Development CorporationLXH2026-07-16
00822409082179N/AOrtho Development CorporationLXH2026-07-16
00822409082186N/AOrtho Development CorporationLXH2026-07-16
00822409082193N/AOrtho Development CorporationLXH2026-07-16
00822409082209N/AOrtho Development CorporationLXH2026-07-16
00822409082216N/AOrtho Development CorporationLXH2026-07-16
00822409082223N/AOrtho Development CorporationLXH2026-07-16
00822409082230N/AOrtho Development CorporationLXH2026-07-16
00822409082247N/AOrtho Development CorporationLXH2026-07-16
00822409082254N/AOrtho Development CorporationLXH2026-07-16
00822409082261N/AOrtho Development CorporationLXH2026-07-16
00822409082278N/AOrtho Development CorporationLXH2026-07-16
00822409082285N/AOrtho Development CorporationLXH2026-07-16
00822409082292N/AOrtho Development CorporationLXH2026-07-16
00822409082308N/AOrtho Development CorporationLXH2026-07-16
00822409082315N/AOrtho Development CorporationLXH2026-07-16
00822409082322N/AOrtho Development CorporationLXH2026-07-16
00822409082339N/AOrtho Development CorporationLXH2026-07-16
00822409082346N/AOrtho Development CorporationLXH2026-07-16
00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16