FDA.report

NA

Primary DI
10886982274007
Brand
NA
Company
Synthes GmbH
Model
03.404.021S
Catalog number
03404021S
Device description
12.5MM REAMER HEAD FOR RIA 2 STERILE
Published
2019-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886982274007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088698227400710886982274007

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer, flexibleAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylindrical device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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