← Back to catalogue

Apelo® / Apelo® MIS

FDA UDI

Class I (US FDA UDI)

by Atlas Spine Inc.

Identity

Trade Name
Apelo® / Apelo® MIS FDA UDI
Generic Name
Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Device Name
Straight Sounding Probe FDA UDI
Model / Reference
2006-31-0000 FDA UDI
Description
Straight Sounding Probe FDA UDI

Identifiers

Catalog Number
2006-31-0000 FDA UDI
Primary DI / UDI-DI
M68120063100000 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Abdominal/ENT/orthopaedic surgical probe, reusable

Apelo® / Apelo® MIS by Atlas Spine Inc. — 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

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

Manufacturer

Manufacturer
Atlas Spine Inc.

Sources (1)

  • FDA UDI e030d5a5-a574-4ad8-a77c-ef6219ebf595 35 fields · synced May 31, 2026