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AVATAR Minimally Invasive Spinal System Instruments

FDA UDI

Class II (US FDA UDI)

by Life Spine, Inc.

Identity

Trade Name
AVATAR Minimally Invasive Spinal System Instruments FDA UDI
Generic Name
Endoscopic-access dilator, reusable FDA UDI
Device Name
DILATION TUBE 5 FDA UDI
Model / Reference
117-321 FDA UDI
Description
DILATION TUBE 5 FDA UDI

Identifiers

Catalog Number
117-321 FDA UDI
Primary DI / UDI-DI
00190837032791 FDA UDI
510(k) Number
K111953 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Endoscopic-access dilator, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic-access dilator, reusable

AVATAR Minimally Invasive Spinal System Instruments by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic-access dilator, reusable.

Cleared under the same submission

K111953 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Life Spine, Inc.

Sources (1)

  • FDA UDI 5c9df200-63c1-49d1-a40e-8e9eb0bd8381 35 fields · synced Jun 1, 2026