Balteum AL.IN.0004

GUDID 08800039887311

Variable drill guide (single barrel)

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID08800039887311
NIH Device Record Key0e55ce0f-867c-4abb-86f7-7ce063ffdce2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalteum
Version Model NumberA
Catalog NumberAL.IN.0004
Company DUNS557795909
Company NameDIOMEDICAL CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039887311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

[08800039887311]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

On-Brand Devices [Balteum]

08800113999114Temporary Fixation pin
08800039887335Awl for Drill Guide
08800039887328Awl with Sleeve
08800039887311Variable drill guide (single barrel)
08800039887304Self-retaining Screwdriver T20
08800039874984Lumbar Plate Variable screw (Self-Tapping) 6.5 x 33
08800039874960Lumbar Plate Variable screw (Self-Tapping) 6.5 x 28
08800039874946Lumbar Plate Variable screw (Self-Tapping) 6.5 x 24
08800039874922Lumbar Plate Variable screw (Self-Tapping) 6.5 x 20
08800039874663Lumbar Plate Variable screw (Self-Tapping) 5.5 x 33
08800039874649Lumbar Plate Variable screw (Self-Tapping) 5.5 x 28
08800039874625Lumbar Plate Variable screw (Self-Tapping) 5.5 x 24
08800039874601Lumbar Plate Variable screw (Self-Tapping) 5.5 x 20
08800039872423Lumbar Plate 1level 25
08800039872416Lumbar Plate 1level 23
08800039872409Lumbar Plate 1level 21
08800039872393Lumbar Plate 1level 19
08800039872386Lumbar Plate 1level 17
08800039872379Lumbar Plate 1level 15
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