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SureTrac(TM) Elastic Traction System

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
SureTrac(TM) Elastic Traction System FDA UDI
Generic Name
Endoluminal self-retaining endoscopic retractor FDA UDI
Device Name
ETD-C-26-165-C-N,ROCC-00001 FDA UDI
Model / Reference
ETS00001 FDA UDI
Description
ETD-C-26-165-C-N,ROCC-00001 FDA UDI

Identifiers

Primary DI / UDI-DI
06932503563017 FDA UDI
510(k) Number
K222354 FDA UDI
FDA Product Code
QSW FDA UDI
GMDN Term
Endoluminal self-retaining endoscopic retractor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4410 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

Dimensions & Sizes

Size
Length — 1650 Millimeter FDA UDI
Outer Diameter — 2.6 Millimeter FDA UDI

Category: Endoluminal self-retaining endoscopic retractor

SureTrac(TM) Elastic Traction System by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoluminal self-retaining endoscopic retractor.

Cleared under the same submission

K222354 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI 3ce1eb1d-eee5-4b8d-aaa9-c6d6d83e2256 36 fields · synced Jun 8, 2026