FDA.report

GluOn-IF

Primary DI
08800104099090
Brand
GluOn-IF
Company
GS Medical Co., Ltd.
Model
GS136-2110
Catalog number
GS136-2110
Device description
Bone Impactor
Published
2023-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWAImpactor

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800104099090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800104099090088001040990908800104099090

GMDN Terms

TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags

DUNS number
688385418
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08800322757574 PYXIS 3D Titanium Cervical Cage, Close0905-55300905-55302026-02-03
08800322757581 PYXIS 3D Titanium Cervical Cage, Close0905-55350905-55352026-02-03
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08800322757604 PYXIS 3D Titanium Cervical Cage, Close0905-55450905-55452026-02-03
08800322757611 PYXIS 3D Titanium Cervical Cage, Close0905-55500905-55502026-02-03
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08800322757635 PYXIS 3D Titanium Cervical Cage, Close0905-55600905-55602026-02-03
08800322757642 PYXIS 3D Titanium Cervical Cage, Close0905-55650905-55652026-02-03
08800322757659 PYXIS 3D Titanium Cervical Cage, Close0905-55700905-55702026-02-03
08800322757666 PYXIS 3D Titanium Cervical Cage, Close0905-65000905-65002026-02-03
08800322757673 PYXIS 3D Titanium Cervical Cage, Close0905-65250905-65252026-02-03
08800322757680 PYXIS 3D Titanium Cervical Cage, Close0905-65300905-65302026-02-03
08800322757697 PYXIS 3D Titanium Cervical Cage, Close0905-65350905-65352026-02-03
08800322757703 PYXIS 3D Titanium Cervical Cage, Close0905-65400905-65402026-02-03
08800322757710 PYXIS 3D Titanium Cervical Cage, Close0905-65450905-65452026-02-03
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08800322757734 PYXIS 3D Titanium Cervical Cage, Close0905-65550905-65552026-02-03
08800322757741 PYXIS 3D Titanium Cervical Cage, Close0905-65600905-65602026-02-03

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