Biolon 62501
GUDID 01369918000007
Viscoelastic surgical aid
AMRING PHARMACEUTICALS INC.
Vitreous/aqueous humour replacement medium, intraoperative| Primary Device ID | 01369918000007 |
| NIH Device Record Key | 2749f09b-5e7c-439c-986a-e3a4ed6a8fed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biolon |
| Version Model Number | version 1 |
| Catalog Number | 62501 |
| Company DUNS | 079843051 |
| Company Name | AMRING PHARMACEUTICALS 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 1 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not Freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00369918000008 [Primary] |
| GS1 | 01369918000007 [Package] Contains: 00369918000008 Package: case [185 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P960011
FDA Product Code
| LZP | AID, SURGICAL, VISCOELASTIC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
[01369918000007]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-17 |
Devices Manufactured by AMRING PHARMACEUTICALS INC.
| 00369918645100 - Lacrifill Canalicular Gel | 2024-04-23 Canalicular gel |
| 01369918000007 - Biolon | 2018-07-06Viscoelastic surgical aid |
| 01369918000007 - Biolon | 2018-07-06 Viscoelastic surgical aid |
Trademark Results [Biolon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOLON 98518501 not registered Live/Pending |
Ferring B.V. 2024-04-25 |
 BIOLON 97818421 not registered Live/Pending |
Milliken & Company 2023-03-01 |
 BIOLON 86979122 4985495 Live/Registered |
Verdezyne, Inc. 2015-02-10 |
 BIOLON 86530213 not registered Dead/Abandoned |
Verdezyne, Inc. 2015-02-10 |
 BIOLON 86446706 5461592 Live/Registered |
Ferring B.V. 2014-11-06 |
 BIOLON 85435160 not registered Dead/Abandoned |
Verdezyne, Inc. 2011-09-29 |
 BIOLON 77708754 3759183 Live/Registered |
NEW IMAGE LABS CORPORATION 2009-04-07 |
 BIOLON 76663864 3374670 Dead/Cancelled |
Bio-Technology General (Israel) Ltd. 2006-07-31 |
 BIOLON 76210721 not registered Dead/Abandoned |
Aberdeen Road Company 2001-02-15 |
 BIOLON 74630640 2235978 Dead/Cancelled |
FERRING B.V. 1995-02-06 |
 BIOLON 74110955 1682317 Dead/Cancelled |
E. I. du Pont de Nemours and Company 1990-10-31 |
 BIOLON 72432831 0972955 Live/Registered |
DENTSPLY INTERNATIONAL INC. 1972-08-15 |
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