FDA.reportPublic FDA data

Shaver Blade 3mm Single Use Double Serrated 60°

Primary DI
10857326005779
Brand
Shaver Blade 3mm Single Use Double Serrated 60°
Company
ENTELLUS MEDICAL, INC.
Model
SSB-12360-1, SSB-12360-5
Device description
The Shaver 3mm Single Use Double Serrated 60° Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.
Published
2020-09-25
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
EQJBur, Ear, Nose And Throat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857326005694PackageGS15In Commercial Distribution
10857326005779PackageGS11In Commercial Distribution
00857326005772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085732600569410857326005694
1085732600577910857326005779
00857326005772008573260057728573260057720857326005772

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017283879
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
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
00857326005536XeroGelXG-1022020-09-10
00857326005543XeroGelXG-1082020-09-10
10850002250210Shaver Blade 2.1mm Reusable Double Serrated StraightSSB-222-02020-09-25
10857326005731Shaver Blade 3mm Reusable Double Serrated Straight SSB-223-02020-09-25
10857326005748Shaver Blade 4mm Reusable Double Serrated Straight SSB-224-02020-09-25
10857326005755Shaver Blade 3mm Single Use Double Serrated StraightSSB-12300-1, SSB-12300-52020-09-25
10857326005762Shaver Blade 3mm Single Use Double Serrated 40° SSB-12340-1, SSB-12340-52020-09-25
10857326005786Shaver Blade 4mm Single Use Double Serrated Straight SSB-12400-1, SSB-12400-52020-09-25
10857326005793Shaver Blade 4mm Single Use Double Serrated 40° SSB-12440-1, SSB-12440-52020-09-25
10857326005809Shaver Blade 4mm Single Use Double Serrated 60° SSB-12460-1, SSB-12460-52020-09-25
10857326005830Shaver Blade 2.1mm Single Use Double Serrated StraightSSB-12200-1, SSB-12200-52020-09-25
00857326005550Entellus Medical Reinforced Anesthesia Needle RANRAN-027-22017-05-18
00857326005574Entellus Medical Reinforced Anesthesia Needle RANRAN-027-52017-05-18
00857037006990LATERALATDD012016-07-21
00857037006983LATERALATANI012016-07-21
00857037006921LATERALATDD242017-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904461028783OSSEOUS- Shaver Blade Tube EON MEDITECH PRIVATE LIMITEDEQJ2026-03-13
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAEQJ2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAEQJ2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAEQJ2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAEQJ2025-03-20
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
08904428723409OSSEOUS Blade - Inferior turbinate - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723416OSSEOUS Blade - Inferior turbinate - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723423OSSEOUS Blade-Straight Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723430OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723447OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723454OSSEOUS Blade-Curved Sinus Blades - TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723461OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723478OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723485OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723492OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723515OSSEOUS Blade - Inferior turbinate - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723539OSSEOUS Blade-Straight Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723546OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723553OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723560OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723577OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000505OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000529OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461001571OSSEOUS Blades-Straight Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000956OSSEOUS Burs-Course DiamondEON MEDITECH PRIVATE LIMITEDEQJ2024-07-05
08904461000888OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04
08904461000895OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04
08904461000901OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04