FDA.reportPublic FDA data

Medline

Primary DI
20888277396590
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
8775AR
Catalog number
8775AR
Device description
8775A C-REAMER DRL BIT 12MM DIA. X 7,S
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277396590PackageGS14In Commercial Distribution
10888277396593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827739659020888277396590
1088827739659310888277396593

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840096408706Viant Medical, LLCVIANT MEDICALHTO2020-09-03
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00840096408720Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408737Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408744Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408751Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408768Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408775Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408782Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408799Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408805Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408812Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408829Viant Medical, LLCVIANT MEDICALHTO2020-09-03
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00840096408843Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408850Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408867Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408874Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408881Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408898Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408904Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408911Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408928Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408935Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408942Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408959Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408966Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408973Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408980Viant Medical, LLCVIANT MEDICALHTO2020-09-03