Device
Layer 1 for uCentum longarm-screws Ø 5.5 and 7.5 mm, perforated
Manufacturer
Ulrich GmbH & Co. KG
Ulrich GmbH & Co. KG
Model: CS 3890-032-001
DI: 04052536220748
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
Layer 1 for uCentum longarm-screws Ø 5.5 and 7.5 mm, perforated
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:
50a8609e-e6fb-4526-bffe-1463630455c2
Distribution Status:
In Commercial Distribution
DUNS Number:
315494757
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
Item #1 - Device ID:
04052536220748
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
04052536083848
Item #2 - Device ID Type:
Previous
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 13730
Name: Device sterilization/disinfection container, reusable
Definition:
A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.
FDA Product Codes
NKB
Orthosis, spinal pedicle fixation, for degenerative disc disease
MNH
Orthosis, spondylolisthesis spinal fixation
MNI
ORTHOSIS, SPINAL PEDICLE FIXATION
Premarket Submissions
Submission Number:
K123717
Supplement Number:
000