FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bipolar Forceps
DI: 00817984010907
·
Model: 0600-BC3310-000
·
MECTRA LABS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bipolar Forceps
- Primary DI
- 00817984010907
- Version / Model
- 0600-BC3310-000
- Catalog Number
- 0600-BC3310-000
- Company Name
- MECTRA LABS, INC.
- Labeler DUNS
- 606939072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-24
- Public Version
- 3
- Public Version Date
- 2020-01-13
- Public Version Status
- Update
- Public Device Record Key
- 1f6931de-f000-477e-b289-927b212adeb9
- Distribution End Date
- 2020-01-10
Device Description
Bipolar Forceps Kleppinger-Style BC 34CM
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 |
|---|---|---|---|---|
| HIN | COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) | Obstetrics/Gynecology | 884.4150 | 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 | 10817984010904 | GS1 | Inner Pack | 5 | Not in Commercial Distribution | 2020-01-10 |
| Primary | 00817984010907 | GS1 |
Customer Contacts
- Phone
- +1(800)323-3968
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 115 Degrees Fahrenheit