Fathom

FDA UDI

Class I (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Fathom FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: Medial Extension Arm, Long, Left FDA UDI
Model / Reference: MR2-103101 FDA UDI
Description: Medial Extension Arm, Long, Left FDA UDI

Identifiers

Catalog Number: MR2-103101 FDA UDI
Primary DI / UDI-DI: 10889981300302 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Surgical retraction system, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retraction system, reusable

A comprehensive medical device directory, providing detailed information about the Fathom Surgical Retraction System.

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Thompson — Thompson Surgical Instruments · Class I

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 I	Pending data

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Manufacturer

Manufacturer: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 8209450e-a874-4234-aaad-9a756c148d2e 35 fields · synced Jun 19, 2026