RIGIDLOOP 232486

GUDID 03760304680229

The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use.

S.B.M

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID03760304680229
NIH Device Record Keyd2d562ad-60a3-4457-afc9-3599dd24139d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGIDLOOP
Version Model NumberBTB Adjustable Cortical System - XL
Catalog Number232486
Company DUNS772462123
Company NameS.B.M
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

Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103760304680229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-28
Device Publish Date2020-12-18

On-Brand Devices [RIGIDLOOP]

03760304680236The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop. The implant is suppli
03760304680229The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop and titanium button, p
03760304680212The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop and titanium button, p
03760304680205The RIGIDLOOP device consists of a titanium button, designed to be used for ACL reconstruction.
03760304680199The RIGIDLOOP device consists of a titanium button, designed to be used for ACL reconstruction.
03760304680182The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop and titanium button, p
03760304680175The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop and titanium button, p

Trademark Results [RIGIDLOOP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RIGIDLOOP
RIGIDLOOP
85803563 4656789 Live/Registered
Johnson & Johnson
2012-12-14
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