| Primary Device ID | 00192896110397 |
| NIH Device Record Key | 13957ba6-3c51-4e31-af5c-d2c4f223ac77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | St. Marks Hand Retractor |
| Version Model Number | 508-323BL |
| 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 | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Length | 7 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896110397 [Primary] |
| FDG | Retractor, Fiberoptic |
| FGN | RETRACTOR, NON-SELF-RETAINING |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896110397]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-28 |
| Device Publish Date | 2021-06-18 |
| 00192896109841 | St. Marks Hand Retractor With Lip Illuminated Blade |
| 00192896110397 | St. Marks Hand Retractor With Lip 15 Degree Angled Tip Illuminated Blade |