FDA.reportPublic FDA data

Medline

Primary DI
20888277368801
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
70138003R
Catalog number
70138003R
Device description
7013-8003 POWERED DISSECTOR BLADE,IRRI
Published
2022-05-13
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
NLYMicrodebrider, ent, high speed, single use, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLYMicrodebrider, Ent, High Speed, Single Use, ReprocessedEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277368801PackageGS16In Commercial Distribution
10888277368804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827736880120888277368801
1088827736880410888277368804

GMDN Terms#

Term, Definition table
TermDefinition
Diamond ENT bur, reprocessedA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into an appropriate handpiece that provides the rotation allowing the user to incise or remove bone in the ear, nose, or throat area during an ear/nose/throat (ENT) procedure. It can be used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing 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
false
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
10080196316809MedlineMSC8722EPMSC8722EP2023-08-15
10080196316816MedlineMSC8744EPMSC8744EP2023-08-15
10193489081053MedlineMSC8422MSC84222023-08-15
10193489081060MedlineMSC8444MSC84442023-08-15
10197344039821MEDLINEHNY19075HNY190752024-10-11
10884389122952MedlineMSC871X8EPMSC871X8EP2023-08-15
10884389155448MedlineMSC8488MSC84882023-08-15
10888277720749MedlineMSC8722EPFMSC8722EPF2023-08-04
10888277720756MedlineMSC8744EPFMSC8744EPF2023-08-04
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055508096PM2-Nose MIS D150Bien-Air Surgery SANLY2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SANLY2025-03-21
07630055508072PM2-S MISBien-Air Surgery SANLY2025-03-21
07630055508065PM2-A MISBien-Air Surgery SANLY2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SANLY2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SANLY2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SANLY2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SANLY2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SANLY2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SANLY2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SANLY2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SANLY2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SANLY2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SANLY2023-02-22
17630055504446Irri clip ORIGO NANO/RAPIDOBien-Air Surgery SANLY2023-02-20
07630055505507ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SANLY2023-02-17
07630055505514ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SANLY2023-02-17
07630055505521ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SANLY2023-02-17
17630055505276ShBlade Straight Ø3.0mm DS StBien-Air Surgery SANLY2023-02-17
17630055505290ShBlade Straight Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
17630055505306ShBlade Straight Ø3.0mm SS StBien-Air Surgery SANLY2023-02-17
17630055505313ShBlade Straight Ø3.5mm SS StBien-Air Surgery SANLY2023-02-17
17630055505283ShBlade Straight Ø3.5mm DS StBien-Air Surgery SANLY2023-02-17
07630055505842RAPIDO MicromotorBien-Air Surgery SANLY2023-02-10
07630055505910PM2-S125Bien-Air Surgery SANLY2023-02-10
07630055505927PM2-S150Bien-Air Surgery SANLY2023-02-10
07630055505934S2 Mini DrillBien-Air Surgery SANLY2023-02-10
17630055502916Bur PM2-95 80K Diam Ø1.0 StBien-Air Surgery SANLY2023-02-10
17630055502954Bur PM2-95 80K Diam Ø4.0 StBien-Air Surgery SANLY2023-02-10
17630055503180Bur PM2-70 80K Steel Ø0.8 StBien-Air Surgery SANLY2023-02-10