Device
PERLA TL NAV. SCREWDRIVER, UNIVERSAL
Manufacturer
SpineArt SA
Model: NAV-IN 33 80-N Catalog: NAV-IN 33 80-N DI: 07640221373601 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
PERLA TL NAV. SCREWDRIVER, UNIVERSAL
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 6122e671-444f-4772-aa6d-7c6411dba44d
Distribution Status: In Commercial Distribution
DUNS Number: 483016148
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 07640221373601
Type: Primary
Issuing Agency: GS1
GMDN
Code: 33968
Name: Surgical screwdriver, reusable
Definition:
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
FDA Product Codes
OLO
Orthopedic Stereotaxic Instrument