FDA.reportPublic FDA data

ShBlade Straight Ø3.5mm SM St

Primary DI
27630055505341
Brand
ShBlade Straight Ø3.5mm SM St
Company
Bien-Air Surgery SA
Model
1600545
Catalog number
1600545-005
Published
2023-02-17
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

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
27630055505341PackageGS15In Commercial Distribution
17630055505344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2763005550534127630055505341
1763005550534417630055505344

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481597719
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
17630055519419Bur PM2-70 80K steel Ø1.5 St11013692026-02-16
17630055519525Bur PM2-70 80K diam EC Ø4.0x80 St11014342026-02-16
27630055519539Bur PM2-70 80K steel Ø2.0 St11013702026-02-16
17630055519549Bur PM2-70 80K steel Ø2.0x80 St11013972026-02-16
17630055519556Bur PM2-70 80K diam Ø1.5 St11013752026-02-16
17630055519563Bur PM2-70 80K diam Ø1.5x80 St11014012026-02-16
17630055519570Bur PM2-70 80K diam EC Ø5.0x80 St11014202026-02-16
17630055519587Bur PM2-70 80K diamC Ø2.0 St11013812026-02-16
27630055519591Bur PM2-70 80K steel Ø2.5 St11013712026-02-16
17630055519600Bur PM2-70 80K steel Ø2.5x80 St11013982026-02-16
17630055519617Bur PM2-70 80K diamC Ø2.0x80 St11014242026-02-16
17630055519624Bur PM2-70 80K diamC Ø2.5x80 St11014252026-02-16
17630055519631Bur PM2-70 80K diamC Ø3.0x80 St11014172026-02-16
17630055519648Bur PM2-70 80K diamC Ø3.5x80 St11014262026-02-16
17630055519655Bur PM2-70 80K diam Ø2.0 St11013762026-02-16
17630055519662Bur PM2-70 80K diam Ø2.0x80 St11014022026-02-16
27630055519676Bur PM2-70 80K steel Ø3.0 St11013722026-02-16
17630055519686Bur PM2-70 80K steel Ø3x80 St11013992026-02-16
17630055519693Bur PM2-70 80K diamC Ø2.5 St11013822026-02-16
17630055519709Bur PM2-70 80K diamC Ø4.0x80 St11014272026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17630055506365Bur PM2-MIS D150 diam Ø4.0 StBien-Air Surgery SANLY2025-03-21
17630055506402HS-Handpiece,angled,95mm,80kBien-Air Surgery SANLY2023-02-22
17630055505504ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SANLY2023-02-17
17630055505511ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SANLY2023-02-17
17630055505528ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SANLY2023-02-17
27630055505297ShBlade Straight Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505303ShBlade Straight Ø3.0mm SS StBien-Air Surgery SANLY2023-02-17
27630055505310ShBlade Straight Ø3.5mm SS StBien-Air Surgery SANLY2023-02-17
27630055505327ShBlade Straight Ø4.0mm SS StBien-Air Surgery SANLY2023-02-17
27630055505334ShBlade Straight Ø3.0mm SM StBien-Air Surgery SANLY2023-02-17
27630055505358ShBlade Straight Ø4.0mm SM StBien-Air Surgery SANLY2023-02-17
27630055505365ShBlade 40°Concv Ø3.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505372ShBlade 40°Concv Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505389ShBlade 40°Convx Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505396ShBlade Laryn Ø3.5x220mm SM StBien-Air Surgery SANLY2023-02-17
27630055505402ShBlade Laryn Ø3.5x270mm SM StBien-Air Surgery SANLY2023-02-17
27630055505419ShBlade 15°Concv Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505426ShBlade 15°Convx Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505433ShBlade 40°Adeno Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505440ShBlade 60°Concv Ø3.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505457ShBlade 60°Concv Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505464ShBlade 60°Convx Ø4.0mm DS StBien-Air Surgery SANLY2023-02-17
27630055505471ShBur Straight cyl Ø3.1mm StBien-Air Surgery SANLY2023-02-17
27630055505488ShBur 15°DCR Ø3.1mm StBien-Air Surgery SANLY2023-02-17
27630055505495ShBur 60°cyl Ø3.0mm StBien-Air Surgery SANLY2023-02-17
1763005550804880K/RAPIDO CableBien-Air Surgery SANLY2023-01-30
20888277368801MedlineMEDLINE INDUSTRIES, INC.NLY2022-05-13