QUALITY

Spectra Medical Devices, LLC Quality Commitment:

  • Provide safe and effective products that satisfy our customer’s needs​
  • Maintain Product Quality and Safety “built in” and not “tested in”​
  • Continually review and improve the effectiveness of the QMS​
  • Ensure compliance to all applicable regulations​
  • We deliver this through aligned objectives, teamwork and open communication​
ISO CERTIFICATE

fda registration #:
1224960

MASSACHUSETTS, U.S.A.
Cert # 0124793​
Expiration 5 Jun 2025​

SOUTH KOREA
Cert# SCC-0074-6​
Expiration 28 Feb 2025​

US & Korea Sites are 13485 ISO Certified​
Spectra Medical Operates a Class 8 Clean Room

Electronic Instructions for Use:

Epidural Needle
SMD-IFU-0003 Revision 004
Guide Wire Introducer Needle
SMD-IFU-0002 Revision 002
Radio Frequency Needle
SMD-IFU-0009 Revision 004
Safe-Cut Safety Scalpel
SMD-IFU-0001 Revision 004

Electronic Instructions for Use:

Epidural Needle
SMD-IFU-0003 Revision 004
Guide Wire Introducer Needle
SMD-IFU-0002 Revision 002
Radio Frequency Needle
SMD-IFU-0009 Revision 004
Safe-Cut Safety Scalpel
SMD-IFU-0001 Revision 004
EchoShot Injection Needle
SMD-IFU-0010 Revision 002
Radio Frequency Needle
(CE Marked, Bulk Non-Sterile)
SMD-IFU-0021 Revision 001
Guidewire Introducer Needle
(CE Marked, Bulk Non-Sterile)
SMD-IFU-0022 Revision 001
EchoShot Injection Needle
(CE Marked, Bulk Non-Sterile)br />SMD-IFU-0023 Revision 001