Archon

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: Archon FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name: Archon Screw, 4.0x16mm Self-Drill Var FDA UDI
Model / Reference: 8780216 FDA UDI
Description: Archon Screw, 4.0x16mm Self-Drill Var FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517203823 FDA UDI
510(k) Number: K131025 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

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: Cardiopulmonary resuscitation mask, single-use

Archon by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary resuscitation mask, single-use.

16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class II
First Aid Only — Acme United Corporation · Class I
10PW - Oklahoma Gas & Electric - Poly White — Certified Safety Manufacturing, Inc. · N
MedSource Emergency Pocket Care Mask, w/o O2 port, Hard Case — MEDSOURCE INTERNATIONAL LLC · Class II
Rescue Breather — O-Two Medical Technologies Inc · Class I
EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
ZLB - 10 - Metra 49-980170 — Certified Safety Manufacturing, Inc. · Class II

Cleared under the same submission

K131025 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nuvasive, Inc.

Sources (1)

FDA UDI b8c2bd16-b764-4298-ac19-49d9e7cfdd17 35 fields · synced Jun 8, 2026