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Perla ®

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name
PERLA ® FDA UDI
Generic Name
Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Device Name
OCCIPITAL COUNTER TORQUE FOR ADJUSTABLE ROD FDA UDI
Model / Reference
CPF-IN 56 40-N FDA UDI
Description
OCCIPITAL COUNTER TORQUE FOR ADJUSTABLE ROD FDA UDI

Identifiers

Catalog Number
CPF-IN 56 40-N FDA UDI
Primary DI / UDI-DI
07640305160134 FDA UDI
FDA Product Code
NKG FDA UDI
KWP FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3075 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic counter-torque/rod-pushing instrument

Perla ® by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic counter-torque/rod-pushing instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA UDI 6b8454de-4066-4ad7-a9ce-898b70b18e00 34 fields · synced Jun 8, 2026