RemeOs™ Screw LAG Solid B-FSL-3538

GUDID 06438394015463

RemeOs™ Screw LAG Solid 3.5 mm x 38 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable

Primary Device ID	06438394015463
NIH Device Record Key	4f1fdd21-8cc5-4110-83a7-f15dae9b028c
Commercial Distribution Status	In Commercial Distribution
Brand Name	RemeOs™ Screw LAG Solid
Version Model Number	B-FSL-3538
Catalog Number	B-FSL-3538
Company DUNS	368715301
Company Name	Bioretec Oy
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter
Width	3.5 Millimeter
Length	38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438394015463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

deNovo: DEN220030

FDA Product Code

QJD	Absorbable Metallic Bone Fixation Fastener

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-20
Device Publish Date	2023-06-12

On-Brand Devices [RemeOs™ Screw LAG Solid]

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

Trademark Results [RemeOs]

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