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Espiner Tissue Retrieval System

FDA UDI

Class II (US FDA UDI)

by Espiner Medical Limited

Identity

Trade Name
ESPINER TISSUE RETRIEVAL SYSTEM FDA UDI
Generic Name
Tissue extraction bag FDA UDI
Device Name
Laparoscopic tissue retrieval sac for use with minimally invasive procedures. FDA UDI
Model / Reference
EMP140ECO-S FDA UDI
Description
Laparoscopic tissue retrieval sac for use with minimally invasive procedures. FDA UDI

Identifiers

Primary DI / UDI-DI
05060358121685 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

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 550 Milliliter FDA UDI

Espiner Tissue Retrieval System by Espiner Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111845 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Espiner Medical Limited

Sources (1)

  • FDA UDI ffc42967-2561-4ab3-b014-3cd997c7fd37 37 fields · synced Jun 6, 2026