MEDIHONEY® HCS DUP31744
GUDID 30381780471398
(ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY
ACELL, INC.
Wound-nonadherent dressing, permeable, antimicrobial| Primary Device ID | 30381780471398 |
| NIH Device Record Key | 44bd58a8-b346-4cf7-84ac-4c75abca3e35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDIHONEY® HCS |
| Version Model Number | 31744 |
| Catalog Number | DUP31744 |
| Company DUNS | 137258252 |
| Company Name | ACELL, 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 | 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 | true |
Customer Support Contacts
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Sterility guanteed in unopened, undamaged pouch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780471394 [Primary] |
| GS1 | 30381780471398 [Package] Contains: 10381780471394 Package: Case [5 Units] In Commercial Distribution |
FDA Product Code
| FRO | Dressing, wound, drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-06-08 |
| Device Publish Date | 2018-10-23 |
Devices Manufactured by ACELL, INC.
| 00386190002056 - MicroMatrix® | 2023-10-10 MicroMatrix® Flex 5cc |
| 30381780471398 - MEDIHONEY® HCS | 2023-06-08(ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY |
| 30381780471398 - MEDIHONEY® HCS | 2023-06-08 (ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY |
| 30381780471428 - MEDIHONEY® Hydrogel | 2023-06-08 (ADHESIVE) HYDROGEL SHEET with LEPTOSPERMUM HONEY |
| 30381780471367 - MediHoney® | 2023-05-12 (NON-ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY |
| 30381780486972 - MediHoney® | 2023-05-11 MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound and Burn Dressing |
| 00386190002681 - Gentrix® | 2020-08-31 Surgical Matrix Thick 16 x 20 cm |
| 00386190002698 - Gentrix® | 2020-08-31 Surgical Matrix Thick 10 x 20 cm |
| 00386190002063 - Cardion™ | 2020-08-21 for Pericardial Repair, 7 x 15 cm |
Trademark Results [MEDIHONEY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDIHONEY 85984150 5003695 Live/Registered |
Comvita Limited 2012-11-20 |
 MEDIHONEY 85982592 4676106 Live/Registered |
Comvita Limited 2012-11-20 |
 MEDIHONEY 85783645 not registered Dead/Abandoned |
Comvita Limited 2012-11-20 |
 MEDIHONEY 75846487 2694376 Live/Registered |
DERMA SCIENCES, INC. 1999-11-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.