FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTRRasp

Product Code Classifications

CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800104099700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800104099700088001040997008800104099700

GMDN Terms

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
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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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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08800322757741 PYXIS 3D Titanium Cervical Cage, Close0905-65600905-65602026-02-03

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