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EDG® Ortho 65mm

FDA UDI

Class II (US FDA UDI)

by Edge Surgical, Inc.

Identity

Trade Name
EDG® Ortho 65mm FDA UDI
Generic Name
Surgical depth gauge, single-use FDA UDI
Device Name
The EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriately length of screw in orthopedic procedures. This device comes sterile and ready to use once removed from its packaging. FDA UDI
Model / Reference
21342-65-01 FDA UDI
Description
The EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriately length of screw in orthopedic procedures. This device comes sterile and ready to use once removed from its packaging. FDA UDI

Identifiers

Primary DI / UDI-DI
00865707000414 FDA UDI
510(k) Number
K091992 FDA UDI
FDA Product Code
OOL FDA UDI
GMDN Term
Surgical depth gauge, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

EDG® Ortho 65mm by Edge Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K091992 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edge Surgical, Inc.

Sources (1)

  • FDA UDI b3e89c9b-ca81-4dfb-bdc8-b626afee8df3 37 fields · synced May 30, 2026