Identity
- Trade Name
- SECQURE Ultimate FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- EndoRetrieval Pouch with 10mm Introducer & 90mm x 145mm Pouch FDA UDI
- Model / Reference
- CQ3442ULT FDA UDI
- Description
- EndoRetrieval Pouch with 10mm Introducer & 90mm x 145mm Pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863634000460 FDA UDI
- 510(k) Number
- K081398 FDA UDI
- FDA Product Code
- KGY FDA UDI
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4100 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
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: Tissue extraction bag
SECQURE Ultimate by Secqure Surgical, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081398 also covers:
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
- SECQURE Ultimate — SECQURE SURGICAL, CORP.
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
- Secqure Surgical, Corp.
Sources (1)
- FDA UDI 0d03c33a-25ed-4661-b2f8-91596b1dbce4 34 fields · synced Jun 8, 2026