FDA UDI
In Commercial Distribution
🇺🇸 United States
JustRight Sealer
DI: 00865163000126
·
Model: JR-SE20
·
JUSTRIGHT SURGICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- JustRight Sealer
- Primary DI
- 00865163000126
- Version / Model
- JR-SE20
- Catalog Number
- JR-SE20
- Company Name
- JUSTRIGHT SURGICAL, LLC
- Labeler DUNS
- 025214641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-10
- Public Version
- 5
- Public Version Date
- 2023-04-20
- Public Version Status
- Update
- Public Device Record Key
- 6d165e78-f06d-4e62-9557-8c8ea9fcde1b
Device Description
JustRight Sealer - single
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
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57944 | Endoscopic electrosurgical handpiece/electrode, bipolar, single-use | A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10865163000123 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00865163000126 | GS1 |
Customer Contacts
- Phone
- +1(866)683-1743
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123662 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Shaft diameter 3 mm | ||
| Device Size Text, specify | Shaft length 20 cm |