FDA.reportPublic FDA data

Pulsar

Primary DI
08800104097782
Brand
Pulsar
Company
GS Medical Co., Ltd.
Model
GS133-3620
Catalog number
GS133-3620
Device description
Slap Hammer
Published
2022-11-01
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
FZYHammer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800104097782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800104097782088001040977828800104097782

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
08800322775561Sheathe BladeGS152-1001GS152-10012026-09-18
08800322775578Sheathe BladeGS152-1002GS152-10022026-09-18
08800322775585Sheathe BladeGS152-1003GS152-10032026-09-18
08800322775592Sheathe BladeGS152-1004GS152-10042026-09-18
08800322775608Sheathe BladeGS152-1005GS152-10052026-09-18
08800322775615Sheathe BladeGS152-1006GS152-10062026-09-18
08800322775622Sheathe BladeGS152-1007GS152-10072026-09-18
08800322775639Sheathe BladeGS152-1008GS152-10082026-09-18
08800322775646Sheathe BladeGS152-1101GS152-11012026-09-18
08800322775653Sheathe BladeGS152-1102GS152-11022026-09-18
08800322775660Sheathe BladeGS152-1103GS152-11032026-09-18
08800322775677Sheathe BladeGS152-1104GS152-11042026-09-18
08800322775684Sheathe BladeGS152-1105GS152-11052026-09-18
08800322775691Sheathe BladeGS152-1106GS152-11062026-09-18
08800322775707Sheathe BladeGS152-1107GS152-11072026-09-18
08800322775714Sheathe BladeGS152-1108GS152-11082026-09-18
08800322776391QUASAR Standalone ACIF System6008-00056008-00052026-09-18
08800322776407QUASAR Standalone ACIF System6008-00066008-00062026-09-18
08800322776414QUASAR Standalone ACIF System6008-00076008-00072026-09-18
08800322776421QUASAR Standalone ACIF System6008-00086008-00082026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093937ELMED INCORPORATEDELMED INCORPORATEDFZY2026-08-18
00824846000907Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FZY2026-08-16
09348811083098INKAThe Trustee for KAISER FAMILY TRUSTFZY2026-07-31
03701089527866AMPLITUDEAMPLITUDE SASFZY2026-07-29
10705034647616N/AMedos International SàrlFZY2026-07-09
00198506091179ELMED INCORPORATEDELMED INCORPORATEDFZY2026-06-03
00810189451162Surgical DesignSurgical Design, Inc.FZY2026-05-23
00810189451483Surgical DesignSurgical Design, Inc.FZY2026-05-23
00198506089114ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
00198506089411ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
10705034579023N/AMedos International SàrlFZY2026-03-05
00840493416472LUX Expandable Interbody SystemXENIX MEDICAL LLCFZY2026-02-24
03662663083638ActivLHighridge Medical, LLCFZY2026-02-03
03662663083645ActivLHighridge Medical, LLCFZY2026-02-03
03662663083652ActivLHighridge Medical, LLCFZY2026-02-03
03662663083669ActivLHighridge Medical, LLCFZY2026-02-03
03662663083676ActivLHighridge Medical, LLCFZY2026-02-03
03662663083690ActivLHighridge Medical, LLCFZY2026-02-03
03662663155618Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155762Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155779Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663244695Vital MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-12-18
04262494463150N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463174N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463167N/ADoppkon GmbH & Co. KGFZY2025-11-28
03662663216951Telluride MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-11-17
03662663267205Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663267601Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663279123Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
00196449034604Anatomic Access LLIFTyber Medical, LLCFZY2025-10-22