| Primary Device ID | 00861838000378 |
| NIH Device Record Key | f4431dd6-664f-49f5-8676-3879ae5cfe48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bariatric Anastomosis Leak Tester |
| Version Model Number | ALT-BA |
| Catalog Number | ALT-BA |
| Company DUNS | 841842441 |
| Company Name | TOOLS FOR SURGERY, LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com | |
| Phone | 6314444448 |
| info@toolsforsurgery.com |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Length | 6.76 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861838000378 [Primary] |
| FCY | Bulb, Inflation, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-04 |
| Device Publish Date | 2019-09-26 |
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| 00860002701394 - Circular Stapler Head Sizer Set | 2023-07-27 Circular Stapler Head Sizer Set includes (1) 25 mm, (1) 29 mm, and (1) 33 mm reusable head sizers that are used to assist in cho |
| 00860002701325 - Barbell Loop Ostomy Device | 2023-07-25 Loop Ostomy Device, Small (2-inch rod). |
| 00860002701349 - Barbell Loop Ostomy Device | 2023-07-25 Loop Ostomy Device, Medium (3-inch rod). |
| 00860002701356 - Barbell Loop Ostomy Device | 2023-07-25 Loop Ostomy Device, Large (4-inch rod). |
| 00860002701363 - SIREN SGT | 2023-07-25 Suction-regulated orogastric calibration tube, 36 Fr |
| 00861838000330 - WIKI Drain, 15 Fr, 3 cm, 1 Drain | 2023-07-25 The WIKI Drain™ is a flanged quadruple-lumen silicone channel drain. Package of 1, 15 Fr, 3 cm drain. |
| 00861838000347 - WIKI Drain, 15 Fr, 3 cm, 6 Drains | 2023-07-25 The WIKI Drain is a flanged quadruple-lumen silicone channel drain. Package contains 6, 15 Fr, 3 cm drains. |