Stratos

FDA UDI

Class I (US FDA UDI)

by A.m. Surgical, Inc.

Identity

Trade Name: Stratos FDA UDI
Generic Name: Hand ligament surgical release instrument FDA UDI
Device Name: Endoscopic Release System FDA UDI
Model / Reference: 5500 FDA UDI
Description: Endoscopic Release System FDA UDI

Identifiers

Primary DI / UDI-DI: 00857915007132 FDA UDI
FDA Product Code: NBH FDA UDI
GMDN Term: Hand ligament surgical release instrument FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1100 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hand ligament surgical release instrument

Stratos by A.m. Surgical, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: A.m. Surgical, Inc.

Sources (1)

FDA UDI 22273025-3784-4e23-ba9a-bd5ae677865b 34 fields · synced Jun 8, 2026