FDA.report

Medline

Primary DI
20888277393643
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
8788R
Catalog number
8788R
Device description
8788 C-REAMER DRL BIT,LONG HEAD 8.0MM
Published
2022-05-12
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
true

Related Records

Contact Domains

Product Codes

CodeName
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277393643PackageGS14In Commercial Distribution
10888277393646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827739364320888277393643
1088827739364610888277393646

GMDN Terms

TermDefinition
Bone-resection orthopaedic reamer, reprocessedAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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

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10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
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10197344039845MEDLINEHNY19150HNY191502024-10-11
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10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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