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Holo

FDA UDI

Class I (US FDA UDI)

by Surgalign Spine Technologies

Identity

Trade Name
HOLO FDA UDI
Generic Name
Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Device Name
HOLO Probe, Lenke, Iliac, Straight FDA UDI
Model / Reference
1505-700220 FDA UDI
Description
HOLO Probe, Lenke, Iliac, Straight FDA UDI

Identifiers

Primary DI / UDI-DI
00810076560281 FDA UDI
FDA Product Code
HXB FDA UDI
GMDN Term
Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Abdominal/ENT/orthopaedic surgical probe, reusable

Holo by Surgalign Spine Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI fc1d99d7-0365-4eac-9371-d4fe05e75b17 34 fields · synced Jun 6, 2026