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Extraction Basket

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref RSEB-S4-15

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name
Extraction Basket FDA UDI
Generic Name
Biliary/urinary stone retrieval basket, single-use FDA UDI
Device Name
Nitinol Spiral Extraction Basket EUDAMED
Basket shape: Four wires spiral; Basket Diameter: 15mm; Basket Length: 40mm; Working Length: 2000mm; FDA UDI
Model / Reference
RSEB-S4-15 EUDAMEDFDA UDI
Description
Basket shape: Four wires spiral; Basket Diameter: 15mm; Basket Length: 40mm; Working Length: 2000mm; FDA UDI

Identifiers

Primary DI / UDI-DI
06902284519558 EUDAMED
06932503511513 FDA UDI
Basic UDI-DI
6902284EB464529K EUDAMED
510(k) Number
K243471 FDA UDI
FDA Product Code
LQR FDA UDI
EMDN Code
G0305010201 DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, REVOLVING EUDAMED
GMDN Term
Biliary/urinary stone retrieval basket, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Dimensions & Sizes

Size
Length — 2000 Millimeter FDA UDI
Outer Diameter — 15 Millimeter FDA UDI

Category: Biliary/urinary stone retrieval basket, single-use

Extraction Basket by Micro-Tech (Nanjing) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Biliary/urinary stone retrieval basket, single-use.

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI dcbc9b72-a657-4310-adab-930e32ff05cb 36 fields · synced Jul 29, 2026
  • EUDAMED 66d2629d-adb7-43b0-b963-4cf8296321da 61 fields · synced Jul 29, 2026