| Primary Device ID | 00844505012089 |
| NIH Device Record Key | 2378b9a8-b00a-4874-9299-843d633c2b0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoEar™ SUCTION |
| Version Model Number | 1.83.05 |
| Company DUNS | 030849173 |
| Company Name | Grace Medical, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com | |
| Phone | +1(866)472-2363 |
| info@gracemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844505012089 [Primary] |
| JZF | Tube, Ear Suction |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
[00844505012089]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-25 |
| Device Publish Date | 2020-08-17 |
| 00844505011990 | EndoEar™ SUCTION SHORT CURVE, 3 FR, UP STAINLESS STEEL |
| 00844505012430 | EndoEar™ SUCTION MEDIUM CURVE, 5 FR, RIGHT STAINLESS STEEL |
| 00844505012416 | EndoEar™ SUCTION SHORT CURVE, 5 FR, LEFT STAINLESS STEEL |
| 00844505012393 | EndoEar™ SUCTION SHORT CURVE, 5 FR, RIGHT STAINLESS STEEL |
| 00844505012157 | EndoEar™ SUCTION LONG CURVE, 3 FR, DOWN STAINLESS STEEL |
| 00844505012133 | EndoEar™ SUCTION LONG CURVE, 3 FR, UP STAINLESS STEEL |
| 00844505012119 | EndoEar™ SUCTION MEDIUM CURVE, 5 FR, DOWN STAINLESS STEEL |
| 00844505012089 | EndoEar™ SUCTION MEDIUM CURVE, 5 FR, UP STAINLESS STEEL |
| 00844505012065 | EndoEar™ SUCTION SHORT CURVE, 24 GA, DOWN STAINLESS STEEL |
| 00844505012027 | EndoEar™ SUCTION SHORT CURVE, 24 GA, UP STAINLESS STEEL |
| 00844505011983 | EndoEar™ SUCTION STRAIGHT, 24 GA STAINLESS STEEL |
| 00844505011976 | EndoEar™ SUCTION STRAIGHT, 20 GA STAINLESS STEEL |
| 00844505011945 | EndoEar™ SUCTION STRAIGHT, 3 FR, STAINLESS STEEL |
| 00844505012454 | EndoEar™ SUCTION MEDIUM CURVE, 5 FR, LEFT STAINLESS STEEL |
| 00844505012423 | EndoEar™ SUCTION MEDIUM CURVE, 3 FR, RIGHT STAINLESS STEEL |
| 00844505012164 | EndoEar™ SUCTION LONG CURVE, 20 GA, DOWN STAINLESS STEEL |
| 00844505012140 | EndoEar™ SUCTION LONG CURVE, 20 GA, UP STAINLESS STEEL |
| 00844505012447 | EndoEar™ SUCTION MEDIUM CURVE, 3 FR, LEFT STAINLESS STEEL |
| 00844505012409 | EndoEar™ SUCTION SHORT CURVE, 3 FR, LEFT STAINLESS STEEL |
| 00844505012386 | EndoEar™ SUCTION SHORT CURVE, 3 FR, RIGHT STAINLESS STEEL |
| 00844505011969 | EndoEar™ SUCTION STRAIGHT, 7 FR, STAINLESS STEEL |
| 00844505011952 | EndoEar™ SUCTION STRAIGHT, 5 FR, STAINLESS STEEL |