FDA.reportPublic FDA data

RIGIDFIX

Primary DI
10886705002986
Brand
RIGIDFIX
Company
Medos International Sàrl
Model
213704
Catalog number
213704
Device description
RIGIDFIX Femoral Step Pin Insertion Rod
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEFAPPLIER, STAPLE, SURGICAL,

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEFApplier, Staple, Surgical,General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705002986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500298610886705002986

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09
10705034647494CROSSNAV CONDUIT3010-21-3143010213142026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653300532HI-LINEAesculap AGGEF2020-04-23
04038653300570HI-LINEAesculap AGGEF2020-04-23
04038653300587HI-LINEAesculap AGGEF2020-04-23
00192896090675MICHEL CLIP APPLIER/REMOVER FORCEPSSONTEC INSTRUMENTS, INC.GEF2019-03-07
10886705013142INTRAFIXDEPUY MITEK, LLCGEF2017-03-17
00889024024540NAZimmer, Inc.GEF2016-07-27
10886705009930NADEPUY MITEK, LLCGEF2015-09-01
10886705010059NADEPUY MITEK, LLCGEF2015-09-01
10886705001910GIIDEPUY MITEK, LLCGEF2015-09-01
10886705001927NADEPUY MITEK, LLCGEF2015-09-01
10886705001934NADEPUY MITEK, LLCGEF2015-09-01
10886705003761GIIDEPUY MITEK, LLCGEF2015-09-01
10886705006809TACITDEPUY MITEK, LLCGEF2015-09-01