| Primary Device ID | 00818501021222 | 
| NIH Device Record Key | 3b849a6e-d9a4-45ec-99a5-df6128017937 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Invotec Silicone Sheeting | 
| Version Model Number | 20-30007 | 
| Catalog Number | 20-30007 | 
| Company DUNS | 622812592 | 
| Company Name | INVOTEC INTERNATIONAL, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00818501021222 [Primary] | 
| LYA | Splint, Intranasal Septal | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00818501021222]
Moist Heat or Steam Sterilization
[00818501021222]
Moist Heat or Steam Sterilization
[00818501021222]
Moist Heat or Steam Sterilization
[00818501021222]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-12-15 | 
| Device Publish Date | 2022-12-07 | 
| 00818501022410 | Invotec Silicone Sheeting 12 x 12 x 0.020" Reinforced | 
| 00818501021918 | Invotec Silicone Sheeting 12 X 12 X 0.040" Blue | 
| 00818501021901 | Silicone Sheeting, Blue, 15cm X 11.5cm X 0.13mm (6.0" X 4.5" X 0.005") | 
| 00818501021338 | Invotec Silicone Sheeting, 12 X 12 X .015" Reinforced | 
| 00818501021321 | Invotec Silicone Sheeting 12 x 12 x 0.020" Reinforced | 
| 00818501021314 | Invotec Silicone Sheeting, 12 x 12 x 0.030 Reinforced | 
| 00818501021307 | Invotec Silicone Sheeting 12 x 12 x 0.040 Reinforced | 
| 00818501021291 | Invotec Silicone Sheeting 12 x 12 x 0.060" | 
| 00818501021284 | Invotec Silicone Sheeting 12 x 12 x 0.050" | 
| 00818501021277 | Invotec Silicone Sheeting 12 x 12 x 0.040" | 
| 00818501021260 | Invotec Silicone Sheeting 12 x 12 x 0.030" | 
| 00818501021253 | Invotec Silicone Sheeting 12 X 12 X 0.020" | 
| 00818501021246 | Invotec Silicone Sheeting 12 X 12 X .015" | 
| 00818501021239 | Invotec Silicone Sheeting 12 x 12 x .010" | 
| 00818501021222 | Invotec Silicone Sheeting 12 X 12 X .007" | 
| 00818501021215 | Invotec Silicone Sheeting 12 X 12 X .005" | 
| 00818501021208 | Invotec Silicone Sheeting, 12 X 12 X 0.0025" | 
| 10818501021182 | Invotec Silicone Sheeting, 15cm X 11.5cm X 0.13mm (6.0" X 4.5" X 0.005") | 
| 10818501021175 | Silicone Sheeting, 15cm X 11.5cm X 0.5mm (6.0" X 4.5" X 0.020") | 
| 10818501021168 | SiliconeSheeting, 15cm X 11.5cm X 1.0mm (6.0" X 4.5" X 0.040") |