FDA UDI
In Commercial Distribution
🇺🇸 United States
Kii Dissecting Balloon
DI: 00607915137229
·
Model: C0H12
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Kii Dissecting Balloon
- Primary DI
- 00607915137229
- Version / Model
- C0H12
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 2
- Public Version Date
- 2020-04-21
- Public Version Status
- Update
- Public Device Record Key
- 40fc6538-3722-4345-9132-80e241560845
Device Description
Round Dissecting Balloon with 11mm Introducer
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44792 | Laparoscopic balloon dissector | A device designed to dissect connective tissue layers creating access to a desired surgical site during a laparoscopic procedure. It typically consists of a cannula, a distention balloon, an obturator, an inflation bulb, and a regulating valve(s). An appropriate endoscope is introduced into the cannula to monitor the dissection and/or the insertion process. Using the inflation bulb, the balloon is inflated to a recommended fill volume exerting pressure on the tissue layers. Once the space is dissected the balloon is deflated and the device replaced by other suitable devices (e.g., trocar/cannula) whilst the peritoneal space is insufflated under low pressure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607915137226 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00607915137229 | GS1 | ||||
| Package | 10607915140196 | GS1 | 3 | In Commercial Distribution |