FDA UDI
In Commercial Distribution
🇺🇸 United States
Kumar Clamp® for Single Port, Bariatrics and Robotics
DI: B361KC2XL0
·
Model: KC2XL
·
NASHVILLE SURGICAL INSTRUMENTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Kumar Clamp® for Single Port, Bariatrics and Robotics
- Primary DI
- B361KC2XL0
- Version / Model
- KC2XL
- Catalog Number
- KC-2XL
- Company Name
- NASHVILLE SURGICAL INSTRUMENTS, LLC
- Labeler DUNS
- 030096122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-15
- Public Version
- 4
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- 2280888e-6e5a-4011-8c93-d7b3782c8c11
Device Description
The Kumar Clamp® for Single Port, Bariatrics and Robotics is a reusable 5mm stainless steel laparoscopic grasper of 45 cm length with long ( 3.8 cm) atraumatic jaws and a channel for introduction of the single use Kumar Catheter®. The system is meant to provide a method of laparoscopic cholangiography.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62667 | Laparoscopic tissue manipulation forceps/working-channel | A rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B361KC2XL0 | HIBCC |
Customer Contacts
- Phone
- 615-382-4996
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973621 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 45 | Centimeter |