FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FIBRIJET
DI: 00815634020504
·
Model: SA-3768
·
Micromedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- FIBRIJET
- Primary DI
- 00815634020504
- Version / Model
- SA-3768
- Company Name
- Micromedics, Inc.
- Labeler DUNS
- 066839630
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-13
- Public Version
- 5
- Public Version Date
- 2023-04-25
- Public Version Status
- Update
- Public Device Record Key
- 34e65b2f-2491-47c4-84ad-9934979b0870
- Distribution End Date
- 2021-03-01
Device Description
360° ENDOSCOPIC APPLICATOR WITH TETHER, 5MM x 40CM, 1:1 RATIO (US Indication)
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
- Yes
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44830 | Open-surgery adhesive/sealant applicator, dual-channel | A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20815634020508 | GS1 | SHIP BOX | 1 | Not in Commercial Distribution | 2021-03-01 |
| Package | 10815634020501 | GS1 | SHELF BOX | 5 | Not in Commercial Distribution | 2021-03-01 |
| Primary | 00815634020504 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122526 | 000 |