RemeOs™ Screw LAG Solid B-FSL-3528

GUDID 06438394015418

RemeOs™ Screw LAG Solid 3.5 mm x 28 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable
Primary Device ID06438394015418
NIH Device Record Keyd0b74421-513e-47ec-a653-5511e402b661
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemeOs™ Screw LAG Solid
Version Model NumberB-FSL-3528
Catalog NumberB-FSL-3528
Company DUNS368715301
Company NameBioretec Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter
Width3.5 Millimeter
Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106438394015418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJDAbsorbable Metallic Bone Fixation Fastener

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-20
Device Publish Date2023-06-12

On-Brand Devices [RemeOs™ Screw LAG Solid]

06438394015470RemeOs™ Screw LAG Solid 3.5 mm x 40 mm
06438394015463RemeOs™ Screw LAG Solid 3.5 mm x 38 mm
06438394015456RemeOs™ Screw LAG Solid 3.5 mm x 36 mm
06438394015449RemeOs™ Screw LAG Solid 3.5 mm x 34 mm
06438394015432RemeOs™ Screw LAG Solid 3.5 mm x 32 mm
06438394015425RemeOs™ Screw LAG Solid 3.5 mm x 30 mm
06438394015418RemeOs™ Screw LAG Solid 3.5 mm x 28 mm
06438394015401RemeOs™ Screw LAG Solid 3.5 mm x 26 mm
06438394015395RemeOs™ Screw LAG Solid 3.5 mm x 24 mm

Trademark Results [RemeOs]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REMEOS
REMEOS
79289412 not registered Live/Pending
Bioretec Oy
2020-05-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.