FDA.reportPublic FDA data

Shaver System

Primary DI
00857326005659
Brand
Shaver System
Company
STRYKER CORPORATION
Model
SSA-104
Device description
Handpiece
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857326005659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857326005659008573260056598573260056590857326005659

GMDN Terms#

Term, Definition table
TermDefinition
ENT shaver system handpieceA handle with attached cutting blade that is a component of a line-powered ENT shaver system and designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It is typically connected to and regulated through a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and may be used in combination with appropriate endoscopic devices. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196548481
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
04546540722768WingspanM003WS0250090M003WS02500902015-05-29
04546540722775WingspanM003WS0250150M003WS02501502015-05-29
04546540722782WingspanM003WS0250200M003WS02502002015-05-29
04546540722799WingspanM003WS0300090M003WS03000902015-05-29
04546540722805WingspanM003WS0300150M003WS03001502015-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAERL2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAERL2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAERL2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAERL2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAERL2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507853Cable for HS-Micro-Motor,largeBien-Air Surgery SAERL2023-02-22
07630055507860Perforator MotorBien-Air Surgery SAERL2023-02-22
07630055505507ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505514ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505521ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505026BASCH MicromotorBien-Air Surgery SAERL2023-02-10
07630055505828BASCH-1 MicromotorBien-Air Surgery SAERL2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAERL2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAERL2023-02-10
07630055505927PM2-S150Bien-Air Surgery SAERL2023-02-10
07630055505934S2 Mini DrillBien-Air Surgery SAERL2023-02-10
07630055508027NANO CableBien-Air Surgery SAERL2023-02-10