Identity
- Trade Name
- Total 5mm solution kit 2 FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- Kit Includes: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CFB12, 5x100 Kii SH BLD ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm Inzii RETRIEVAL SYSTEM, 10/BX FDA UDI
- Model / Reference
- GK118 FDA UDI
- Description
- Kit Includes: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CFB12, 5x100 Kii SH BLD ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm Inzii RETRIEVAL SYSTEM, 10/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20607915126241 FDA UDI
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 access cannula, single-useTissue extraction bag
Total 5mm solution kit 2 by Applied Medical Resources Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI f6d0abcf-f0a9-4ff3-b086-d16e678e8234 34 fields · synced Jun 1, 2026