FDA UDI
In Commercial Distribution
🇺🇸 United States
Infibra
DI: 08056099230004
·
Model: IF1T
·
BIOLOREN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Infibra
- Primary DI
- 08056099230004
- Version / Model
- IF1T
- Company Name
- BIOLOREN SRL
- Labeler DUNS
- 428561679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 309fcf4d-6e45-4b22-b092-1ec7098d2b45
Device Description
Spool, 1 mm tubular, refill
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44786 | Dental reinforcing fibre | A device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056099230004 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061735 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 2 | Millimeter |