FDA.reportPublic FDA data

N/A

Primary DI
10705034579634
Brand
N/A
Company
Medos International Sàrl
Model
698345182
Catalog number
698345182
Device description
ROD BENDER, RIGHT 4.0mm
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034579634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503457963410705034579634

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10878528000645ENVOY671-260-95D67126095D2016-06-30
10878528000652ENVOY671-258-95D67125895D2016-06-30
10878528000669ENVOY671-260-05D67126005D2016-06-30
10878528000676ENVOY671-258-05D67125805D2016-06-30
10878528000898REVIVERC044115RC0441152016-06-30
10878528000911REVIVERC044130RC0441302016-06-30
10878528000942REVIVERC056115RC0561152016-06-30
10878528000959REVIVERC056125RC0561252016-06-30
10886704074816ENVOY671-256-05D67125605D2016-06-30
10886704075066ENVOY671-256-95DB67125695DB2016-06-30
10886704075073ENVOY671-256-95D67125695D2016-06-30
10886704075080ENVOY671-256-05DB67125605DB2016-06-30
10886704075097ENVOY671-258-05DB67125805DB2016-06-30
10886704075103ENVOY671-260-05DB67126005DB2016-06-30
10886704075110ENVOY671-258-95DB67125895DB2016-06-30
10886704075127ENVOY671-260-95DB67126095DB2016-06-30
10886704079248YOGAMC24150ZMC24150Z2017-10-31
10886704079255YOGAMC24150ZBMC24150ZB2017-10-31
10886704079262YOGAMC28150ZMC28150Z2017-10-31
10886704079415YOGAMC28150ZBMC28150ZB2017-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034579627N/AMedos International SàrlHXW2026-08-14
00840606191654Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
00840606191661Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
00840606191760Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
B8034709150ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709160ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709170ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709180ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709190ORTHOMEDORTHO-MED, INC.HXW2026-07-14
008401944958133P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958203P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958373P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958443P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958513P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
08809695601781GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809695630187GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809885726911Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
08809885726928Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
08809885798017Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17
10705034576985N/ADEPUY SPINE, LLCHXW2024-12-16
10887587077635NASynthes GmbHHXW2024-08-21
10887587077963NASynthes GmbHHXW2024-08-21
G079C5040000010Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23