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Spider

FDA UDI

Class I (US FDA UDI)

by Sintea Plustek, LLC

Identity

Trade Name
SPIDER FDA UDI
Generic Name
Endoscopic-access dilator, single-use FDA UDI
Model / Reference
SPS10N125 FDA UDI

Identifiers

Primary DI / UDI-DI
08033726407060 FDA UDI
510(k) Number
K072198 FDA UDI
FDA Product Code
HXG FDA UDI
GMDN Term
Endoscopic-access dilator, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Endoscopic-access dilator, single-use

Spider by Sintea Plustek, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic-access dilator, single-use.

Cleared under the same submission

K072198 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sintea Plustek, LLC

Sources (1)

  • FDA UDI 1a4d2d5e-9412-46eb-bca3-04b5b2b1d51d 33 fields · synced Jun 1, 2026