FDA UDI
In Commercial Distribution
🇺🇸 United States
Curved Dynablator® XL
DI: 00859273007274
·
Model: R-10027
·
RELIGN CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Curved Dynablator® XL
- Primary DI
- 00859273007274
- Version / Model
- R-10027
- Catalog Number
- R-10027
- Company Name
- RELIGN CORPORATION
- Labeler DUNS
- 080031617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-18
- Public Version
- 2
- Public Version Date
- 2025-05-30
- Public Version Status
- Update
- Public Device Record Key
- 33e4205a-4e39-4893-b382-addb4de8c106
Device Description
CURVED DYNABLATOR XL
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61872 | Endoscopic electrosurgical electrode, bipolar, single-use | An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859273007271 | GS1 | BX | 4 | In Commercial Distribution | |
| Primary | 00859273007274 | GS1 |
Customer Contacts
- Phone
- +1(866)608-0131
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241008 | 000 |