HELICOLL HC2x4
GUDID 00860000744416
HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x4 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.
ENCOLL CORP.
Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing| Primary Device ID | 00860000744416 |
| NIH Device Record Key | 6b1a03d4-459a-4185-8626-2bf690c6ae1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HELICOLL |
| Version Model Number | HC2x4 |
| Catalog Number | HC2x4 |
| Company DUNS | 962858049 |
| Company Name | ENCOLL CORP. |
| Device Count | 5 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com | |
| Phone | 510 396 8581 |
| guna@encoll.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000744416 [Unit of Use] |
| GS1 | 10860000744413 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040314
FDA Product Code
| KGN | Dressing, Wound, Collagen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-11 |
On-Brand Devices [HELICOLL]
| 00860000744447 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 13 mm dia disc |
| 00860000744430 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 8x8 inches inte |
| 00860000744423 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 4x4 inches inte |
| 00860000744416 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x4 inches inte |
| 00860000744409 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x2 inches inte |
| 00860000744485 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.6x1.6 inches |
| 00860000744478 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.2x1.6 inches |
| 00860000744461 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 0.8x1.6 inches |
| 00860000744454 | HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 25 mm dia disc |
Trademark Results [HELICOLL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HELICOLL 90683481 not registered Live/Pending |
Encoll Corp 2021-04-30 |
 HELICOLL 85782538 4506817 Live/Registered |
Mid-Continent Technologies, LLC 2012-11-19 |
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