Low Profile Cable BIO-1-1012-A

GUDID B046BIO11012A0

Low Profile Cable

SIGNAL MEDICAL CORPORATION

Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile
Primary Device IDB046BIO11012A0
NIH Device Record Key84fe8612-277a-4fd7-97bb-5d5b56d3dc35
Commercial Distribution StatusIn Commercial Distribution
Brand NameLow Profile Cable
Version Model Number1.5mm Cable
Catalog NumberBIO-1-1012-A
Company DUNS169289308
Company NameSIGNAL MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com
Phone8103647070
Emailvfowler@signalmd.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB046BIO11012A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDQCerclage, Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-03
Device Publish Date2021-08-26

Devices Manufactured by SIGNAL MEDICAL CORPORATION

B046BIO110930 - Straight Osteotome2023-05-02 Straight Osteotome 1/2"
B046BIO110440 - Knee Osteogator2023-03-22 Knee Osteogator
B046BIO110830 - PCL Retractor2023-03-01 PCL Retractor
B046BIO11081 - Femoral Belt2022-06-27 Femoral Belt
B046BIO110430 - Alligator Rongeur2022-05-20 9" Alligator Rongeur
B046BIO11082 - Tibial Belt2022-05-20 Tibial Belt
B046BIO110840 - Lateral Retractor2022-05-20 Lateral Retractor
B046BIO110910 - Mallet Tip - Teflon2022-04-01 Mallet Tip - Teflon

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