Identity
- Trade Name
- KIT KE018 COLEC1 FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- Kit Contains: C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CTF33, 11x100 Kii Fios ZTHR 6/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX FDA UDI
- Model / Reference
- GK209 FDA UDI
- Description
- Kit Contains: C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CTF33, 11x100 Kii Fios ZTHR 6/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20607915129365 FDA UDI
- FDA Product Code
- MDM FDA UDIHET FDA UDINWV FDA UDIGCJ FDA UDIFZP FDA UDI
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI884.1720 FDA UDI876.1500 FDA UDI878.4300 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-useEndoscopic electrosurgical handpiece/electrode, monopolar, single-useTissue extraction bag
Kit Ke018 Colec1 by Applied Medical Resources Corp. — Class I — 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 17f37576-a3aa-46ea-b5ba-31ede0e9d25e 34 fields · synced May 31, 2026