| Primary Device ID | B492202343 |
| NIH Device Record Key | f057b675-deee-47c1-bdb9-77b0437b0487 |
| Commercial Distribution Discontinuation | 2018-07-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Vitale |
| Version Model Number | 20234 |
| Catalog Number | 20234 |
| Company DUNS | 960091929 |
| Company Name | CELLERA 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com | |
| Phone | 800-892-2391 |
| sales@cellerallc.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B492202340 [Primary] |
| HIBCC | B492202341 [Package] Contains: B492202340 Package: box [10 Units] Discontinued: 2018-07-31 Not in Commercial Distribution |
| HIBCC | B492202342 [Package] Contains: B492202341 Package: case [10 Units] Discontinued: 2018-07-31 Not in Commercial Distribution |
| HIBCC | B492202343 [Package] Contains: B492202342 Package: overpack [4 Units] Discontinued: 2018-07-31 Not in Commercial Distribution |
| NAC | Dressing,Wound,Hydrophilic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-07 |
| Device Publish Date | 2017-06-22 |
| 10856276008786 | Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case |
| 10856276008762 | Vitale Calcium Alginate Dressings with Antibacterial Silver, 2" x 2", 10/box, 10 boxes/case |
| 10856276008748 | Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case |
| 10856276008724 | Vitale Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case |
| 10856276008700 | Vitale Calcium Alginate Dressings with Antimicrobial Silver, 4" x 5", 10/box, 10 boxes/case |
| 10856276008687 | Vitale Non-Adhesive Foam Dressings, 4" x 4", 10/box, 10 boxes/case |
| 10856276008663 | Vitale Calcium Alginate Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case |
| 10856276008649 | Vitale Calcium Alginate Ropes with Antibacterial Silver, 5/box, 10 boxes/case |
| 10856276008625 | Vitale Foam Heel Dressings, 6" x 7", 5/box, 10 boxes/case |
| 10856276008601 | Vitale Adhesive Foam Dressings, 6" x 6", 10/box, 10 boxes/case |
| 10856276008588 | Vitale Adhesive Foam Dressings, 4" x 4", 10/box, 10 boxes/case |
| 00856276008567 | Vitale Sacral Silicone Dressings, 1/pouch, 5/box, 40 boxes/case |
| 10856276008533 | Vitale Hydroconductive Dressings, 6" x 8", 1/pouch, 10/box, 10 boxes/case |
| 10856276008519 | Vitale Thin Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case |
| 10856276008496 | Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case |
| 10856276008472 | Vitale Cover Dressings, 4" x 14", 20/box, 10 boxes/case |
| 10856276008434 | Vitale Sacral Hydrocolloid Dressings, 6" x 7", 1/pouch, 10/box, 10 boxes/case |
| 10856276008410 | Vitale Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case |
| 10856276008397 | Vitale Calcium Alginate Ropes, 5/box, 10 boxes/case |
| 00856276008352 | Vitale Composite dressings, 6" x 6", 1/pouch, 30/box, 8 boxes/case |
| 10856276008229 | Vitale Hydrocolloid Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case |
| 00856276008208 | Vitale Silicone Foam Dressings, 6" x 6", 10/box, 10 boxes/case, 4 cases/overpack |
| 10856276008175 | Vitale Hydroconductive Dressings, 4" x 5", 1/pouch, 10/box, 10 boxes/case |
| 00856276008154 | Vitale Silicone Foam Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case, 4 cases/overpack |
| 10856276008120 | Vitale Cover Dressings, 2" x 2", 30/box, 8 boxes/case |
| 00856276008109 | Vitale Composite Dressings, 1/pouch, 30/box, 8 boxes/case |
| 10856276008083 | Vitale Hydroconductive Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case |
| 00856276008062 | Vitale Hydroconductive Dressings, 2"x2", 1/pouch, 10/box, 10 boxes/case |
| 00856276008055 | Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case |
| 10856276008281 | Vitale Silicone Super-Absorbent Dressings, 8" x 10", 10/box, 10 boxes/case |
| 00856276008017 | Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack |
| 00856276008253 | Vitale Silicone Super-Absorbent Dressing, 3.5" x 4", 10/box, 10 boxes/case, 4 cases/overpack |
| 10850005565038 | Vitale Sacral Silicone Super-Absorbent Dressings, 5/box, 10 boxes/case |
| B492245062 | Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case |
| B492245042 | Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case |
| B492245022 | Vitale Cover Dressings, 2" x 2", 30/box, 8 boxes/case |
| B492238440 | Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case |
| B492238222 | Vitale Hydrogel Impregnated Dressing, 2x2, 1/pouch, 10/box, 10 boxes/case |
| B492212900 | Vitale Sacral Hydrocolloid Dressing, 6x7, 1/pouch, 10/box, 10 boxes/case |
| B492212442 | Vitale Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case |
| B492212222 | Vitale Hydrocolloid Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case |
| B492210442 | Vitale Thin Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case |
| B492208452 | Vitale Hydroconductive Dressings, 4" x 5", 1/pouch, 10/box, 10 boxes/case |
| B492208442 | Vitale Hydroconductive Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case |
| B492208222 | Vitale Hydroconductive Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case |
| B492208002 | Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case |
| B492206452 | Vitale Calcium Alginate Dressings, 4" x 5", 10/box, 10 boxes/case |
| B492206442 | Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case |
| B492206222 | Vitale Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case |
| B492206002 | Vitale Calcium Alginate Ropes, 5/box, 10 boxes/case |