FDA.reportPublic FDA data

ShBlade Straight Ø4.0 DS RU St

Primary DI
17630055505528
Brand
ShBlade Straight Ø4.0 DS RU St
Company
Bien-Air Surgery SA
Model
1600581
Catalog number
1600581-001
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
17630055505528PackageGS11In Commercial Distribution
27630055505525PackageGS11In Commercial Distribution
07630055505521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763005550552817630055505528
2763005550552527630055505525
07630055505521076300555055217630055505521

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
false
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
27630055509653Long Microsaw Blade 32x0.4mm 15026791502679-0012026-04-21
27630055517672Left Inferior Boarder Osteotomy Blade15027231502723-0012026-04-21
47630055517676Left Inferior Boarder Osteotomy Blade15027231502723-0102026-04-21
27630055509479Short Microsaw Blade 22x0.4mm15026711502671-0012026-04-21
27630055509585Short Microsaw Blade 27x0.4mm15026721502672-0012026-04-21
27630055509592Short Microsaw Blade 32x0.4mm15026731502673-0012026-04-21
27630055509608Short Microsaw Blade 22x0.6mm15026741502674-0012026-04-21
27630055509615Short Microsaw Blade 27x0.6mm15026751502675-0012026-04-21
27630055509622Short Microsaw Blade 32x0.6mm15026761502676-0012026-04-21
27630055509639Long Microsaw Blade 22x0.4mm15026771502677-0012026-04-21
27630055509646Long Microsaw Blade 27x0.4mm15026781502678-0012026-04-21
27630055509660Long Microsaw Blade 22x0.6mm15026801502680-0012026-04-21
27630055509677Long Microsaw Blade 27x0.6mm15026811502681-0012026-04-21
27630055509684Long Microsaw Blade 32x0.6mm15026821502682-0012026-04-21
27630055517641Right Inferior Boarder Osteotomy Blade15027221502722-0012026-04-21
27630055517702Short Oscillating Blade 6x0.4mm15027241502724-0012026-04-21
27630055517733Short Oscillating Blade 9x0.4mm15027251502725-0012026-04-21
27630055517764Long Oscillating Blade 6x0.4mm15027261502726-0012026-04-21
27630055517795Long Oscillating Blade 9x0.4mm15027271502727-0012026-04-21
27630055517825Short Sagittal Blade 6x0.4mm15027431502743-0012026-04-21

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