FDA.reportPublic FDA data

Medline

Primary DI
20888277385563
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
5091143R
Catalog number
5091143R
Device description
5091-143 MICRO BUR,SWANSON REAMER,MD,
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
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277385563PackageGS15In Commercial Distribution
10888277385566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827738556320888277385563
1088827738556610888277385566

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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
10080196377299MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10080196385577MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10884389198537MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10653160274797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160276982CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160281672CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160282402CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160290797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160321668CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10845854018125STERLINGConmed CorporationGFF2021-10-15
10845854017210STERLINGConmed CorporationGFF2021-10-14
10845854029596CONMEDConmed CorporationGFF2021-10-14
10845854029602CONMEDConmed CorporationGFF2021-10-14
10845854029619STERLING SOUTHPAWConmed CorporationGFF2021-10-14
10845854017432STERLINGConmed CorporationGFF2021-10-13
10845854017593STERLINGConmed CorporationGFF2021-10-13
10845854036563STERLING SOUTHPAWConmed CorporationGFF2021-10-13
10845854000687CONMEDConmed CorporationGFF2020-09-24
10845854000717CONMEDConmed CorporationGFF2020-09-24
10845854000724CONMEDConmed CorporationGFF2020-09-24
10845854000755CONMEDConmed CorporationGFF2020-09-24
10845854000779CONMEDConmed CorporationGFF2020-09-24