Primary Device ID | 00192896121959 |
NIH Device Record Key | 980f8888-bd8e-4b2c-a244-b3b06b9b263c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Heartline Atrial Ball Lock |
Version Model Number | 2800-5200 |
Catalog Number | 2800-5200 |
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 |
Phone | +1(800)821-7496 |
info@sontecinstruments.com | |
Phone | +1(800)821-7496 |
info@sontecinstruments.com | |
Phone | +1(800)821-7496 |
info@sontecinstruments.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00192896121959 [Primary] |
GAD | RETRACTOR |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00192896121959]
Dry Heat Sterilization
[00192896121959]
Dry Heat Sterilization
[00192896121959]
Dry Heat Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-18 |
Device Publish Date | 2025-08-08 |
00192896121959 - Heartline Atrial Ball Lock | 2025-08-18Heartline Atrial Ball Lock |
00192896121959 - Heartline Atrial Ball Lock | 2025-08-18 Heartline Atrial Ball Lock |
00192896121966 - Heartline Crilewood Needle Holder | 2025-08-18 Heartline Crilewood Needle Holder With Lock Straight Tungsten Carbide Jaw Squeeze Handle |
00192896121973 - Heartline Ryder Needle Holder | 2025-08-18 Heartline Ryder Needle Holder With Lock Tungsten Carbide Jaw Squeeze Handle |
00192896121980 - Heartline Gemini Dissection Forceps | 2025-08-18 Heartline Gemini Dissection Forceps Spreading Jaw |
00192896121997 - Heartline Debakey Grasper | 2025-08-18 Heartline Debakey Grasper Tungsten Carbide Jaw Squeeze Handle |
00192896121850 - Nylon Head For Deluxe Mallet | 2025-08-11 Nylon Head For Deluxe Mallet Model 1 |
00192896121867 - Nylon Head For Deluxe Mallet | 2025-08-11 Nylon Head For Deluxe Mallet Model 2 |
00192896121874 - Wood Valve Retractor | 2025-08-11 Wood Valve Retractor Double Ended 28/40 X 20 Millimeters Tips Stainless |