FDA UDI
In Commercial Distribution
🇺🇸 United States
ORISE™ ProKnife
DI: 08714729999898
·
Model: M00519361
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORISE™ ProKnife
- Primary DI
- 08714729999898
- Version / Model
- M00519361
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-18
- Public Version
- 1
- Public Version Date
- 2020-12-28
- Public Version Status
- New
- Public Device Record Key
- 75f14caf-6695-4bdd-af61-8c2968cb3e14
Device Description
ORISE PROKNIFE 2.0 mm Electrode
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 |
|---|---|---|---|---|
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62228 | Endoscopic electrosurgical submucosal lift/resection instrument | A flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) an electrosurgical current in a monopolar configuration (i.e., with a return electrode) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It is a long, thin electrode/luminal needle with an electrical cable and delivery tube to enable connection to the appropriate parent devices (i.e., electrosurgical system generator and fluid pump); it does not include any controls. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729999898 | GS1 |