FDA UDI
In Commercial Distribution
🇺🇸 United States
ScopeSafe™ Laser Fiber with Soft Tip
DI: B145115210
·
Model: 11521
·
OPTICAL INTEGRITY INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ScopeSafe™ Laser Fiber with Soft Tip
- Primary DI
- B145115210
- Version / Model
- 11521
- Company Name
- OPTICAL INTEGRITY INC
- Labeler DUNS
- 024050887
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-21
- Public Version
- 6
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 4f02e41b-41b8-4970-814e-06925e000c9a
Device Description
272 micrometer ScopeSafe™ Laser Fiber with Soft Tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61474 | General/multiple surgical laser system beam guide, reusable | A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B145115211 | HIBCC | Box | 3 | In Commercial Distribution | |
| Primary | B145115210 | HIBCC |
Customer Contacts
- Phone
- 8502335512
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022338 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 272 | Micrometer |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 37 Degrees Celsius