FDA.report

C-REAMER

Primary DI
20845854019167
Brand
C-REAMER
Company
Conmed Corporation
Model
8786
Catalog number
8786
Device description
C-Reamer, Cannulated 6.0mm
Published
2022-12-22
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
GFGBIT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845854019167PackageGS14In Commercial Distribution
10845854019160PrimaryGS10
00845854019163Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585401916720845854019167
1084585401916010845854019160
00845854019163008458540191638458540191630845854019163

GMDN Terms

TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone) and precisely shape a specific area of bone to accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); some types may in addition be designed to be used endoscopically to resect hypertrophic tissue [e.g., ligamentum flavum] to relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
4
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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