← Back to catalogue
Kii Dissecting Balloon
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref C0H11Model Kii® Dissecting Balloons
Identity
- Trade Name
- Kii Dissecting Balloon Access Systems EUDAMEDKii Dissecting Balloon FDA UDI
- Generic Name
- Laparoscopic balloon dissector FDA UDI
- Device Name
- Kii® Dissecting Balloons EUDAMEDOval dissecting balloon with 11mm Introducer FDA UDI
- Model / Reference
- C0H11 EUDAMEDFDA UDIKii® Dissecting Balloons EUDAMED
- Description
- Oval dissecting balloon with 11mm Introducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915136703 EUDAMEDFDA UDI
- Basic UDI-DI
- 0607915IIA019G9 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020101 MINIMALLY INVASIVE SURGERY DISSECTORS, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic balloon dissector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laparoscopic balloon dissector
Kii Dissecting Balloon by Applied Medical Resources Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic balloon dissector.
- Spacemaker — Covidien LP · Class II
- Extra View — Covidien LP · Class II
- Spacemaker Plus — Covidien LP · Class II
- PDB — Covidien LP · Class II
- Spacemaker — Covidien LP · Class II
- Spacemaker — Covidien LP · Class II
- Spacemaker Plus — Covidien LP · Class II
- Spacemaker — Covidien LP · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (2)
- FDA UDI 602c66f5-a087-49c4-bf3b-97e0949a0f89 33 fields · synced Jul 8, 2026
- EUDAMED dfd1d61f-929e-463b-9376-7b515e8fb30f 61 fields · synced Jul 8, 2026