FDA UDI
In Commercial Distribution
🇺🇸 United States
Stryker
DI: B504CBEN60000
·
Model: EN6000
·
Provision
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Stryker
- Primary DI
- B504CBEN60000
- Version / Model
- EN6000
- Company Name
- Provision
- Labeler DUNS
- 016889401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-22
- Public Version
- 1
- Public Version Date
- 2024-05-30
- Public Version Status
- New
- Public Device Record Key
- f2d19e0b-2918-4feb-8619-ceaf66c27b72
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61817 | Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed | 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; it may in addition be intended for open surgery. 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 previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B504CBEN60000 | HIBCC |
Customer Contacts
- Phone
- 541-422-8880
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172647 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 7 – 32 Degrees Celsius