Invotec Silicone Sheeting 20-20685B

GUDID 00818501021901

Silicone Sheeting, Blue, 15cm X 11.5cm X 0.13mm (6.0" X 4.5" X 0.005")

INVOTEC INTERNATIONAL, INC.

Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable
Primary Device ID00818501021901
NIH Device Record Key42d50792-0144-4d71-ba0b-d96f920371c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameInvotec Silicone Sheeting
Version Model Number20-20685B
Catalog Number20-20685B
Company DUNS622812592
Company NameINVOTEC INTERNATIONAL, INC.
Device Count1
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100818501021901 [Primary]

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00818501021901]

Moist Heat or Steam Sterilization


[00818501021901]

Moist Heat or Steam Sterilization


[00818501021901]

Moist Heat or Steam Sterilization


[00818501021901]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [Invotec Silicone Sheeting]

00818501022410Invotec Silicone Sheeting 12 x 12 x 0.020" Reinforced
00818501021918Invotec Silicone Sheeting 12 X 12 X 0.040" Blue
00818501021901Silicone Sheeting, Blue, 15cm X 11.5cm X 0.13mm (6.0" X 4.5" X 0.005")
00818501021338Invotec Silicone Sheeting, 12 X 12 X .015" Reinforced
00818501021321Invotec Silicone Sheeting 12 x 12 x 0.020" Reinforced
00818501021314Invotec Silicone Sheeting, 12 x 12 x 0.030 Reinforced
00818501021307Invotec Silicone Sheeting 12 x 12 x 0.040 Reinforced
00818501021291Invotec Silicone Sheeting 12 x 12 x 0.060"
00818501021284Invotec Silicone Sheeting 12 x 12 x 0.050"
00818501021277Invotec Silicone Sheeting 12 x 12 x 0.040"
00818501021260Invotec Silicone Sheeting 12 x 12 x 0.030"
00818501021253Invotec Silicone Sheeting 12 X 12 X 0.020"
00818501021246Invotec Silicone Sheeting 12 X 12 X .015"
00818501021239Invotec Silicone Sheeting 12 x 12 x .010"
00818501021222Invotec Silicone Sheeting 12 X 12 X .007"
00818501021215Invotec Silicone Sheeting 12 X 12 X .005"
00818501021208Invotec Silicone Sheeting, 12 X 12 X 0.0025"
10818501021182Invotec Silicone Sheeting, 15cm X 11.5cm X 0.13mm (6.0" X 4.5" X 0.005")
10818501021175Silicone Sheeting, 15cm X 11.5cm X 0.5mm (6.0" X 4.5" X 0.020")
10818501021168SiliconeSheeting, 15cm X 11.5cm X 1.0mm (6.0" X 4.5" X 0.040")

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.