I-SiL Jumbo Heavy Body

GUDID 08809262958034

Spident Co., Ltd.

Silicone dental impression material
Primary Device ID08809262958034
NIH Device Record Key3d13f98e-4f23-4f2f-9c37-c9f34697397f
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-SiL Jumbo Heavy Body
Version Model Number102-0602
Company DUNS689370711
Company NameSpident 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100020080921224 [Package]
Package: [110 Units]
Discontinued: 2022-09-21
In Commercial Distribution
GS102018122616236 [Package]
Package: [500 Units]
Discontinued: 2019-12-31
In Commercial Distribution
GS102021023519025 [Package]
Package: [50 Units]
In Commercial Distribution
GS108809262958034 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-17
Device Publish Date2017-02-20

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