Identity
- Trade Name
- STANDARD KIT 4 FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- Kit Contains: CTR12, 5x100 Kii OPT ZTHR DP 10/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX FDA UDI
- Model / Reference
- GK201 FDA UDI
- Description
- Kit Contains: CTR12, 5x100 Kii OPT ZTHR DP 10/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20607915129136 FDA UDI
- FDA Product Code
- HET FDA UDIGCJ FDA UDIFZP FDA UDIMDM FDA UDI
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI876.1500 FDA UDI878.4300 FDA UDI878.4800 FDA UDI
- 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: Ligation clip, metallicLaparoscopic access cannula, single-useTissue extraction bagSpring-loaded pneumoperitoneum needle, single-use
Standard Kit 4 by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spring-loaded pneumoperitoneum needle, single-use.
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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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI fde2fea2-de9c-4805-86f0-4c9ac900c5d1 34 fields · synced May 30, 2026