MediHoney® 31805
GUDID 30381780486972
MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound and Burn Dressing
ACELL, INC.
Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial| Primary Device ID | 30381780486972 |
| NIH Device Record Key | ff7537f5-8925-4367-8d19-c7b8562b6bd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MediHoney® |
| Version Model Number | 31805 |
| Catalog Number | 31805 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
| Device Size Text, specify | 0 |
| Total Volume | 15 Milliliter |
| Total Volume | 0.5 Fluid Ounce |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| 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 *Do not use if package is damaged |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780486978 [Primary] |
| GS1 | 30381780486972 [Package] Contains: 10381780486978 Package: Case [4 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 | 2023-05-11 |
| Device Publish Date | 2018-09-14 |
On-Brand Devices [MediHoney®]
| 30381780486972 | MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound and Burn Dressing |
| 30381780471367 | (NON-ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY |
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 |
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