FDA.reportPublic FDA data

NA

Primary DI
37613154631927
Brand
NA
Company
STRYKER CORPORATION
Model
5400001030
Catalog number
5400-001-030
Device description
Safety Slide
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
37613154631927PackageGS13In Commercial Distribution
07613154631926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315463192737613154631927
07613154631926076131546319267613154631926

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHERL2025-07-08
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
J021304680001S-10 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021304700001S-12 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303930011M-MH40 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2023-10-12
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