FDA UDI
In Commercial Distribution
🇺🇸 United States
Biolon
DI: 15060156070373
·
Model: version 1
·
ALTACOR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Biolon
- Primary DI
- 15060156070373
- Version / Model
- version 1
- Catalog Number
- 62501
- Company Name
- ALTACOR LIMITED
- Labeler DUNS
- 346153906
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-07
- Public Version
- 1
- Public Version Date
- 2022-06-15
- Public Version Status
- New
- Public Device Record Key
- 96541455-637c-416e-b750-b0949f2fbf6a
Device Description
Viscoelastic surgical aid
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZP | AID, SURGICAL, VISCOELASTIC | Ophthalmic | 886.4275 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15060156070380 | GS1 | case | 185 | In Commercial Distribution | |
| Primary | 15060156070373 | GS1 |
Customer Contacts
- Phone
- +4401182210150
- [email protected]
Premarket Submissions
| 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 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter | |
| Device Size Text, specify | Device Size Text, specify: 1 ml of Biolon solution in prefilled syringe |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Special Storage Condition, Specify: Do not Freeze
- Type
- Special Storage Condition, Specify
- Special Conditions
- Special Storage Condition, Specify: Protect from light
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius