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Perla ® Tl

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name
PERLA ® TL FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
CORTICAL BONE SCREW Ø6.5 L50 FDA UDI
Model / Reference
TLF-CS 65 50-N FDA UDI
Description
CORTICAL BONE SCREW Ø6.5 L50 FDA UDI

Identifiers

Catalog Number
TLF-CS 65 50-N FDA UDI
Primary DI / UDI-DI
07640305166945 FDA UDI
FDA Product Code
KWP FDA UDI
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile 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

Yes

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

Dimensions & Sizes

Size
Length — 50 Millimeter FDA UDI
Outer Diameter — 6.5 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

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

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA UDI 8b2b3087-9c85-40aa-96c0-30dcd067eb98 35 fields · synced May 31, 2026