| Primary Device ID | 00192896107397 |
| NIH Device Record Key | 9c6c9fed-957f-4d0b-9472-00c7d078d012 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helveston Tissue Retractor |
| Version Model Number | 10-5487 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Length | 5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896107397 [Primary] |
| HNI | Retractor, ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896107397]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-22 |
| Device Publish Date | 2021-04-14 |
| 00192896072343 | HELVESTON TISSUE RETRACTOR SINGLE ENDED CURVED BLADE FLAT HANDLE |
| 00192896012516 | HELVESTON TISSUE RETRACTOR CURVED BLADE FLAT HANDLE TITANIUM |
| 00192896012509 | HELVESTON TISSUE RETRACTOR CURVED BLADE FLAT HANDLE TITANIUM |
| 00192896012493 | HELVESTON TISSUE RETRACTOR CURVED BLADE FLAT HANDLE TITANIUM |
| 00192896107403 | Helveston Tissue Retractor Flat Handle 9 Millimeters Curved Blades |
| 00192896107397 | Helveston Tissue Retractor Flat Handle 7 Millimeters Curved Blades |