FDA.report

GluOn-IF

Primary DI
08800104099151
Brand
GluOn-IF
Company
GS Medical Co., Ltd.
Model
GS136-1356
Catalog number
GS136-1356
Device description
Graft Holder, 16x18mm_Bottom
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800104099151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800104099151088001040991518800104099151

GMDN Terms

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
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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08800322757611 PYXIS 3D Titanium Cervical Cage, Close0905-55500905-55502026-02-03
08800322757628 PYXIS 3D Titanium Cervical Cage, Close0905-55550905-55552026-02-03
08800322757635 PYXIS 3D Titanium Cervical Cage, Close0905-55600905-55602026-02-03
08800322757642 PYXIS 3D Titanium Cervical Cage, Close0905-55650905-55652026-02-03
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08800322757697 PYXIS 3D Titanium Cervical Cage, Close0905-65350905-65352026-02-03
08800322757703 PYXIS 3D Titanium Cervical Cage, Close0905-65400905-65402026-02-03
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08800322757741 PYXIS 3D Titanium Cervical Cage, Close0905-65600905-65602026-02-03

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