FDA UDI
In Commercial Distribution
🇺🇸 United States
Optiguide® Cylindrical Fiber Optic Diffuser
DI: 00376128000261
·
Model: 250
·
Pinnacle Biologics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optiguide® Cylindrical Fiber Optic Diffuser
- Primary DI
- 00376128000261
- Version / Model
- 250
- Company Name
- Pinnacle Biologics, Inc.
- Labeler DUNS
- 833037612
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-30
- Public Version
- 3
- Public Version Date
- 2022-03-18
- Public Version Status
- Update
- Public Device Record Key
- 65885a19-ab7c-4caf-923f-5b4c47365672
Device Description
5.0cm rigid fiber optic diffuser for use in photodynamic therapy.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVG | System, Laser, Fiber Optic, Photodynamic Therapy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61471 | Gastrointestinal photodynamic therapy laser beam guide | A sterile, hand-held, probe-like device intended to be used in conjunction with an oncological laser system for directing and delivering laser energy to the upper gastrointestinal (GI) tract (e.g., oesophagus, stomach, duodenum) during photodynamic therapy (PDT) for local cancer treatment; it is not intended to be used for other laser applications (e.g., ablation, excision, vaporization). It typically consists of a fibreoptic cable with a distal probe inserted via the oral cavity, and is available in a variety of configurations for each section of the upper GI tract. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00376128000261 | GS1 |
Customer Contacts
- Phone
- 1-866-248-2039
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P940010 | 001 |
| P940010 | 002 |
| P940010 | 003 |
| P940010 | 004 |
| P940010 | 005 |
| P940010 | 006 |
| P940010 | 007 |
| P940010 | 008 |
| P940010 | 009 |
| P940010 | 010 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5.0 | Centimeter |