Identity
- Trade Name
- JustRight 5mm Retrieval bag, 125ml FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- JustRight 5mm Retrieval bag, 125ml, 10 bags/case FDA UDI
- Model / Reference
- JR-125 ECO-10 FDA UDI
- Description
- JustRight 5mm Retrieval bag, 125ml, 10 bags/case FDA UDI
Identifiers
- Catalog Number
- JR-125 ECO-10 FDA UDI
- Primary DI / UDI-DI
- 00850346007016 FDA UDI
- 510(k) Number
- K111845 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Ethylene Oxide FDA UDI
JustRight 5mm Retrieval bag, 125ml by Justright Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K111845 also covers:
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
- ESPINER TISSUE RETRIEVAL SYSTEM — ESPINER MEDICAL LIMITED
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
- Justright Surgical
Sources (1)
- FDA UDI 7c2320e9-5cec-4f6e-9492-3d62b09258a9 38 fields · synced Jun 1, 2026