FDA.reportPublic FDA data

Medline

Primary DI
20080196385574
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
5091144R
Catalog number
5091144R
Device description
5091-144 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
20080196385574PackageGS15In Commercial Distribution
10080196385577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2008019638557420080196385574
1008019638557710080196385577

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
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