| Primary Device ID | B09928000350 |
| NIH Device Record Key | 5eb8998b-2396-4d70-89b0-f41dd1e4fe81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEARTLINE NEEDLE HOLDER |
| Version Model Number | 2800-035 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Length | 23.5 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 23.5 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896006843 [Primary] |
| HIBCC | B09928000350 [Previous] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B09928000350]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B09928000350]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2018-08-22 |
| B0992800035S0 | HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE |
| B09928000350 | HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE |
| B0992800030S0 | HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE |
| B0992800035L0 | HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE |
| B0992800030L0 | HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE |
| 00192896110496 | Heartline Needle Holder With Lock 1, 2 X 8, 5 Millimeter Tungsten Carbide Dust Jaw Curved Squeez |