S1

GUDID 08800045217300

Bone grafting material - Dental

MedPark co.,Ltd.

Dental bone matrix implant, animal-derived
Primary Device ID08800045217300
NIH Device Record Key43d7641b-5d7f-4ebd-a8cd-b194b9d79f9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameS1
Version Model NumberS1-XB-P300
Company DUNS694921042
Company NameMedPark co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800045217300 [Primary]

FDA Product Code

NPMBone Grafting Material, Animal Source

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-31
Device Publish Date2023-10-23

On-Brand Devices [S1]

08800045217355Bone grafting material - Dental
08800045217348Bone grafting material - Dental
08800045217331Bone grafting material - Dental
08800045217324Bone grafting material - Dental
08800045217317Bone grafting material - Dental
08800045217300Bone grafting material - Dental
08800045217294Bone grafting material - Dental
08800045217287Bone grafting material - Dental
08800045217270Bone grafting material - Dental
08800045217263Bone grafting material - Dental
08800045217256Bone grafting material - Dental

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