DEVICE: Biolon (15060156070373)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 35907 | Vitreous/aqueous humour replacement medium, intraoperative |
A nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LZP | AID, SURGICAL, VISCOELASTIC |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P960011 | 001 |
| P960011 | 002 |
| P960011 | 003 |
| P960011 | 004 |
| P960011 | 005 |
| P960011 | 006 |
| P960011 | 007 |
| P960011 | 008 |
| P960011 | 009 |
| P960011 | 010 |
| P960011 | 011 |
| P960011 | 012 |
| P960011 | 013 |
| P960011 | 014 |
| P960011 | 015 |
| P960011 | 016 |
| P960011 | 017 |
| P960011 | 018 |
| P960011 | 019 |
| P960011 | 020 |
| P960011 | 021 |
| P960011 | 022 |
| P960011 | 023 |
| P960011 | 024 |
| P960011 | 025 |
| P960011 | 026 |
| P960011 | 027 |
| P960011 | 028 |
| P960011 | 029 |
| P960011 | 030 |
| P960011 | 031 |
| P960011 | 032 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Special Storage Condition, Specify: Do not Freeze |
| Special Storage Condition, Specify: Special Storage Condition, Specify: Protect from light |
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Total Volume: 1 Milliliter |
| Device Size Text, specify: Device Size Text, specify: 1 ml of Biolon solution in prefilled syringe |
Device Record Status
96541455-637c-416e-b750-b0949f2fbf6a
June 15, 2022
1
June 07, 2022
June 15, 2022
1
June 07, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 15060156070380 | 185 | 15060156070373 | In Commercial Distribution | case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401182210150
pv@altacor-pharma.com
pv@altacor-pharma.com