Solanas

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: Solanas FDA UDI
Generic Name: Surgical depth gauge, single-use FDA UDI
Device Name: SMALL DEPTH GAUGE 2.7/4.0 FDA UDI
Model / Reference: 10603 FDA UDI
Description: SMALL DEPTH GAUGE 2.7/4.0 FDA UDI

Identifiers

Primary DI / UDI-DI: 00844856000049 FDA UDI
FDA Product Code: HTJ FDA UDI
GMDN Term: Surgical depth gauge, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4300 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 depth gauge, single-use

Solanas by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
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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: Alphatec Spine, Inc.

Sources (1)

FDA UDI ea58ecb7-5ba1-494f-a108-05b076b152e1 34 fields · synced Jun 8, 2026