FDA.reportPublic FDA data

Medline

Primary DI
10888277385566
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
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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24
10653160395720MEDLINEDYNDC3637DYNDC36372026-10-24
10653160395751MEDLINEECVC8657ECVC86572026-10-24
10653160395782MEDLINEEBSI1426BEBSI1426B2026-10-24
10653160395799MEDLINEECVC2440CECVC2440C2026-10-24
10653160395805MEDLINEEBSI1687AEBSI1687A2026-10-24
10653160395812MEDLINEEBSI1356AEBSI1356A2026-10-24
10653160395850MEDLINEECVC7295AECVC7295A2026-10-24
10653160395867MEDLINEEBSI1590AEBSI1590A2026-10-24
10653160395881MEDLINEECVC2770AECVC2770A2026-10-24
10653160395911MEDLINEEBSI1529AEBSI1529A2026-10-24
10653160395959MEDLINEDYNDV2823DYNDV28232026-10-24
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10884389194775MEDLINEMDS9911MDS99112016-10-14
10884389194799MEDLINEMDS9911MQMDS9911MQ2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613053232KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613054222KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613167298KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613205525KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613266892KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268599KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268612KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268650KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021289G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021291G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226031156AU1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226017146A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226046554A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001998KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613002322KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613266915KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613267578KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613272435KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613273418KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31