HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD 222454

GUDID 10886705030842

HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERMATAPE Braided Flat Suture, 38" (96 cm) and (1) White/Blue/Green, Size 2 (5 metric) DYNACORD Braided Suture, 36" (91cm), (1) Utility Shuttle Suture 4.5mm

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID10886705030842
NIH Device Record Key916410ca-183e-4421-b79d-cf0e311a1502
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD
Version Model Number222454
Catalog Number222454
Company DUNS482661753
Company NameMedos International Sàrl
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705030842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, fixation, biodegradable, soft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-19
Device Publish Date2019-07-11

On-Brand Devices [HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD]

10886705030941HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided
10886705030934HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE B
10886705030927HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided
10886705030910HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE B
10886705030903HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided
10886705030897HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE B
10886705030880HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERM
10886705030873HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blu
10886705030866HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERM
10886705030859HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blu
10886705030842HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERM
10886705030835HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blu

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