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Zavation

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name
Zavation FDA UDI
Generic Name
Lumbar interspinous decompression instrument set, reusable FDA UDI
Device Name
Paddle Distractor 14 FDA UDI
Model / Reference
ZAV-1194-D-14 FDA UDI
Description
Paddle Distractor 14 FDA UDI

Identifiers

Primary DI / UDI-DI
00842166187559 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
Lumbar interspinous decompression instrument set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 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: Lumbar interspinous decompression instrument set, reusable

Zavation by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar interspinous decompression instrument set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zavation

Sources (1)

  • FDA UDI 2f88e7d0-1768-448a-8f1a-ae45aa64ef6f 34 fields · synced May 30, 2026