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Perla ® Tl

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name
PERLA ® TL FDA UDI
Generic Name
Orthopaedic rod reducer FDA UDI
Device Name
ROCKER FDA UDI
Model / Reference
TLF-IN 04 20-N FDA UDI
Description
ROCKER FDA UDI

Identifiers

Catalog Number
TLF-IN 04 20-N FDA UDI
Primary DI / UDI-DI
07640185349315 FDA UDI
FDA Product Code
KWP FDA UDI
NKB FDA UDI
GMDN Term
Orthopaedic rod reducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic rod reducer

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

Similar devices

Also classified as Orthopaedic rod reducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA UDI 0be8dda9-f927-40af-9186-a6ade8bdc473 34 fields · synced Jun 7, 2026