Services

UDI GS1 barcode in linear, human readable, and 2D marking capabilities
Compliant with 21CFR201.45
Field inventory rework
FDA UDI compliant direct part marking (DPM):
Materials Expertise:
Metals – 17-4 SS, 300 SeriesS SS, 400 Series SS, Titanium, Aluminum, Cobalt Chrome
Plastics – POM-C, POM, H, PPSU, PEEK, PMMA, Polypropylene, PTFE, ABS, Polycarbonate
Medical Devices – Implants, Non-Implants and Instruments

Cleaning & Passivation description for implants, non-implants and instruments
100% Automated, State of the art ESMA E992 automated passivation system
Ultrasonic washer, citric tank, citric/nitric tank, alkaline (base) tank and two (2) di hot water rinse tanks
Hmi controls
Ph and conductivity monitors
Andon lighting
OEM current production

GS1 barcode in linear form
GS1 barcode in 2d data-matrix format
FDA UDI compliant labels
Pouch sealing
Labeling
Distribution services

Facilities, Equipment and Process Validation
Machines – Mills Lathes, EDMs and Ancillary Equipment
Special Processes – Heat Treatment, Passivation, CMM, Laser
Facilities – HVAC, Compressors, Boilers, RO Systems
Equipment – Freezers, Coolers, Storage
Clean Room Validation

Processes

Validated process for traditional and UDI laser marking
Compliant with 21CFR201.45
Validated 100% automated citric and nitric passivation process
Validated deionized water process
Validated non-CER traditional and UDI labeling and packaging process
Just-in-time (JIT) production
Two-shift production

Equipment

ISO 13485 and ISO 9001 Certified Facility
PRISYM labeling and packaging system
FOBA M2000 and M3000 laser systems with intelligent mark position vision system
Certified Class 8 20’x34’ Clean Environmental Room
Belco STC2016 and STC2520 Sealers and Tunnels
SAP Accounting and Operations