OsteoBridge™

Primary DI: 04048266079114
Brand: OsteoBridge™
Company: Merete GmbH
Model: GA31615
Device description: OsteoBridge IKA Knee Arthrodesis Trial Nail with Collar DIA 16/30 Length 150 mm non-sterile
Published: 2021-11-01
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: true
Single use: false

Related Records

Contact Domains

merete-medical.com

Product Codes

Code	Name
HWT	TEMPLATE

Product Code Classifications

Code	Device	Specialty	Class
HWT	Template	Orthopedic	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
04048266079114	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
04048266079114	04048266079114	4048266079114

GMDN Terms

Term	Definition
Diaphysis prosthesis	An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.

Term

Definition

Diaphysis prosthesis

An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.

Sterilization Methods

Method

Moist Heat or Steam Sterilization

Contacts

Phone	Email
+1(630)869-1092	service@merete-medical.com

Regulatory Flags

DUNS number: 313267265
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company

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04048266076823	N/A	FH20050		2024-07-01
04048266077080	N/A	FH90001		2024-07-01
04048266078490	N/A	FP91021		2024-07-01
04048266167316	N/A	AI14002		2024-07-01
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04048266183354	N/A	CH15003D		2024-06-28
04048266183361	N/A	CH15004D		2024-06-28
04048266183378	N/A	CH15005D		2024-06-28
04048266183385	N/A	CH15006D		2024-06-28
04048266183392	N/A	CH15009D		2024-06-28
04048266183408	N/A	CH15010D		2024-06-28
04048266183415	N/A	CH15011D		2024-06-28
04048266183422	N/A	CH15012D		2024-06-28
04048266183439	N/A	CH15013D		2024-06-28
04048266164346	Merete® CS Cortical Screw Fully Threaded	3.0 40 T10	CR30340T	2024-03-19
04048266010322	TwistCut™ EndoSorb bioabsorbable Snap-Off Screw	2.5 28	FP25028	2015-10-15
04048266040664	OsteoBridge™ Clamping Screw	M3.5	GB30312	2015-10-15
04048266141019	MetaFix™ LS Locking Screw	3.0 26 T10	FH30026S	2016-04-22

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