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Distal Depth Gauge

FDA UDI

Class II (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name
DISTAL DEPTH GAUGE FDA UDI
Generic Name
Surgical depth gauge, reusable FDA UDI
Model / Reference
0514-200 FDA UDI

Identifiers

Primary DI / UDI-DI
00848665002164 FDA UDI
510(k) Number
K012190 FDA UDI
K021008 FDA UDI
K070444 FDA UDI
K123569 FDA UDI
K132005 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Surgical depth gauge, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical depth gauge, reusable

Distal Depth Gauge by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical depth gauge, reusable.

Cleared under the same submission

K012190 also covers:

K021008 also covers:

K070444 also covers:

K123569 also covers:

K132005 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Orthopaedic Solutions, Inc.

Sources (1)

  • FDA UDI 74ec74c4-d97e-4ca5-8ca9-a8e3a148b1d8 34 fields · synced May 31, 2026