SeaSpine

FDA UDI

Class II (US FDA UDI)

by Tedan Surgical Innovations, L.l.c.

Identity

Trade Name: SeaSpine FDA UDI
Generic Name: Analytical non-scalp cutaneous lead FDA UDI
Device Name: Disposable Dilator Kit Kit Contains: ML-0444S Insulated Dilator Set, 7, 12, & 15 MM, Sterile ML-0445 Stimulation Clip, 5-22mm, Single Use, 1/Each, Sterile FDA UDI
Model / Reference: ML-0459 FDA UDI
Description: Disposable Dilator Kit Kit Contains: ML-0444S Insulated Dilator Set, 7, 12, & 15 MM, Sterile ML-0445 Stimulation Clip, 5-22mm, Single Use, 1/Each, Sterile FDA UDI

Identifiers

Primary DI / UDI-DI: 00851797006429 FDA UDI
FDA Product Code: IKD FDA UDI
PDQ FDA UDI
GMDN Term: Analytical non-scalp cutaneous lead FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1175 FDA UDI
874.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 15 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI
Width — 7 Millimeter FDA UDI

Category: Analytical non-scalp cutaneous lead

SeaSpine by Tedan Surgical Innovations, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tedan Surgical Innovations, L.l.c.

Sources (1)

FDA UDI ba8471b5-db92-4a4b-8390-051ce23919d1 34 fields · synced May 30, 2026