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1004-C

FDA UDI

Class I (US FDA UDI)

by Tianjin Newtrans Technology Development

Identity

Trade Name
1004-C FDA UDI
Generic Name
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Model / Reference
1004-C FDA UDI

Identifiers

Primary DI / UDI-DI
16973881680115 FDA UDI
FDA Product Code
MNL FDA UDI
GMDN Term
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical instrument/endoscope cleaning utensil, single-use

1004-C by Tianjin Newtrans Technology Development — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument/endoscope cleaning utensil, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tianjin Newtrans Technology Development

Sources (1)

  • FDA UDI 518a8ec3-042e-4be6-a183-26d43d201d8b 32 fields · synced Jun 8, 2026