HNM SPORTS MEDICINE HNM-OBAL-80-TI

GUDID 00842962105160

ETHOS ADJUSTABLE BUTTON, (2) #5 SUTURE

HNM STAINLESS, LLC.

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 ID00842962105160
NIH Device Record Keyf543effa-01fe-442c-b33f-7264499f0951
Commercial Distribution StatusIn Commercial Distribution
Brand NameHNM SPORTS MEDICINE
Version Model NumberHNM-OBAL-80-TI
Catalog NumberHNM-OBAL-80-TI
Company DUNS806754185
Company NameHNM STAINLESS, LLC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842962105160 [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 Date2020-12-04
Device Publish Date2020-11-26

On-Brand Devices [HNM SPORTS MEDICINE]

00812171029991ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 3.3mm X 10mm, (1) #2 SUTURE
00812171029984ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 3.3mm X 6mm, (1) #2 SUTURE
00812171029977ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 2.9mm x 10mm, (1) #2 SUTURE
00812171029960ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 2.9mm x 6mm, (1) #2 SUTURE
00812171029953ETHOS PRO LABRAL ANCHOR, TITANIUM, 3.3mm X 10mm, (1) #2 SUTURE
00812171029946ETHOS PRO LABRAL ANCHOR, TITANIUM, 3.3mm x 6mm, (1) #2 SUTURE
00812171029939ETHOS PRO LABRAL ANCHOR, TITANIUM, 2.9mm x 10mm, (1) #2 SUTURE
00812171029922ETHOS PRO LABRAL ANCHOR, TITANIUM, 2.9mm x 6mm, (1) #2 SUTURE
00812171029915ETHOS PRO LABRAL ANCHOR, PEEK, 3.3mm x 10mm, (1) #2 SUTURE
00812171029908ETHOS PRO LABRAL ANCHOR, PEEK, 3.3mm x 6mm, (1) #2 SUTURE
00812171029892ETHOS PRO LABRAL ANCHOR, PEEK, 2.9mm x 10mm, (1) #2 SUTURE
00812171026297ETHOS BUTTON CL, 35mm LOOP, (2) #5 SUTURE
00812171026259ETHOS BUTTON CL, 30mm LOOP, (2) #5 SUTURE
00812171023722ETHOS LATERAL ANCHOR, PEEK, W/TITANIUM TIP, 6.5mm x 20mm, KNOTLESS
00812171023715ETHOS LATERAL ANCHOR, PEEK, W/TITANIUM TIP, 5.5mm x 20mm, KNOTLESS
00812171023708ETHOS LATERAL ANCHOR, PEEK, W/TITANIUM TIP, 4.5mm x 20mm, KNOTLESS
00812171023692ETHOS BUTTON CL, 25mm LOOP, (2) #5 SUTURE
00812171023685ETHOS BUTTON CL, 20mm LOOP, (2) #5 SUTURE
00812171023678ETHOS MEDIAL ANCHOR, TITANIUM, 6.5mm x 15mm, (2) #2 SUTURE
00812171023661ETHOS MEDIAL ANCHOR, TITANIUM, 5.5mm x 15mm, (2) #2 SUTURE
00812171023654ETHOS MEDIAL ANCHOR, TITANIUM, 4.5mm x 15mm, (2) #2 SUTURE
00812171023425ETHOS LATERAL ANCHOR, PEEK, W/PEEK TIP, 6.5mm x 20mm, KNOTLESS
00812171023418ETHOS LATERAL ANCHOR, PEEK, W/PEEK TIP, 5.5mm x 20mm, KNOTLESS
00812171023401ETHOS LATERAL ANCHOR, PEEK, W/PEEK TIP, 4.5mm x 20mm, KNOTLESS
00812171023395ETHOS XT ANCHOR, PEEK, 6.5mm x 15mm, (3) #2 SUTURE
00812171023388ETHOS XT ANCHOR, PEEK, 5.5mm x 15mm, (3) #2 SUTURE
00812171023371ETHOS MEDIAL ANCHOR, PEEK, 6.5mm x 15mm, (2) #2 SUTURE
00812171023364ETHOS MEDIAL ANCHOR, PEEK, 5.5mm x 15mm, (2) #2 SUTURE
00812171023357ETHOS MEDIAL ANCHOR, PEEK, 4.5mm x 15mm, (2) #2 SUTURE
00812171023340DISPOSABLE BIPOLAR ABLATOR, 1.8MM, NON-ASPIRATING, 60°
00812171023333DISPOSABLE BIPOLAR ABLATOR, 2.4MM, NON-ASPIRATING, 55°
00812171023326DISPOSABLE BIPOLAR ABLATOR, 3.3MM, NON-ASPIRATING, 90°
00812171023319DISPOSABLE BIPOLAR ABLATOR, 3.3MM, ASPIRATING, 90°
00812171023302DISPOSABLE BIPOLAR ABLATOR, 3.3MM, NON-ASPIRATING, 50°
00812171023296DISPOSABLE BIPOLAR ABLATOR, 3.3MM, ASPIRATING, 50°
00812171022671ETHOS BUTTON CL, 15mm LOOP, (2) #5 SUTURE
00812171022633ETHOS PRO LABRAL ANCHOR, PEEK, 2.9mm x 6mm, (1) #2 SUTURE
00812171022626ETHOS PRO LABRAL ANCHOR, PEEK, 2.9mm x 10mm, (2) #2 SUTURE
00812171020783ETHOS PRO SMALL JOINT ANCHOR XL, TITANIUM, 2.9mm x 10mm, (2) #2 SUTURE
00812171020516ETHOS PRO SMALL JOINT ANCHOR XL, TITANIUM, 2.9mm x 6mm, (2) #2 SUTURE
00842962104125ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 2.9mm x 6mm, (2) #2 SUTURE W/(4) MO-6 NEEDLE, 5/PK
00842962104118ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 10mm, (2) #4-0 SUTURE W/(4) C-1 NEEDLE, 5/PK
00842962104101ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 6mm, (2) #4-0 SUTURE W/(4) C-1 NEEDLE, 5/PK
00842962104095ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10mm, (2) #4-0 SUTURE W/(4) C-1 NEEDLE, 5/PK
00842962104088ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 6mm, (2) #4-0 SUTURE W/(4) C-1NEEDLE, 5/PK
00842962104071ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 10mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
00842962104064ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 6mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
00842962104057ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
00842962104040ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 6mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
00842962104033ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 10mm, (2) #2-0 SUTURE W/(4) CT-2 NEEDLE, 5/PK
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