Sycamore Wood Wedges

GUDID 00348783004878

WEDGE BOX OF 400 - 13T

PREMIER DENTAL PRODUCTS COMPANY

Dental wedge, single-use
Primary Device ID00348783004878
NIH Device Record Keyfe8c74e0-764e-470a-ad4a-9997ae2c4ea6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSycamore Wood Wedges
Version Model Number9061101
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
Device Count4
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100348783004878 [Unit of Use]
GS100348783005035 [Primary]

FDA Product Code

JEPRetainer, Matrix

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-14
Device Publish Date2024-08-06

On-Brand Devices [Sycamore Wood Wedges]

00348783005103WEDGE BOX OF 400 ASSORTED (13T, 13, 15, UT)
00348783004922WEDGE BOX OF 400 ULTRA THINS
00348783004939WEDGE BOX OF 400 MINI
00348783004915WEDGE BOX OF 400 - 17
00348783004908WEDGE BOX OF 400 - 16
00348783004892WEDGE BOX OF 400 - 15
00348783004861WEDGE BOX OF 400 - 13XT
00348783004878WEDGE BOX OF 400 - 13T
00348783004885WEDGE BOX OF 400 - 13

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