NA

Primary DI
00643169945395
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
3152480
Device description
SPRAY 3152480 SILICONE INSTRUMENT
Published
2017-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LTBCYCLOSPORINE RADIOIMMUNOASSAY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTBCyclosporine RadioimmunoassayClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844377000SILICONETreace Medical, Inc.1985-03-18

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169945395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169945395006431699453956431699453950643169945395

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument maintenance lubricantA non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000945817ApexCut EM187BL4012EM2026-10-24
00763000945824ApexCut EM187BL4040EM2026-10-24
00763000945831ApexCut EM187BL4060EM2026-10-24
00763000945848ApexCut EM187BL2975EM2026-10-24
00763000945855ApexCut EM187BL3590EM2026-10-24
00763000957858ApexCut EM187BL4000LEM2026-10-24
20763000089652SLIDE-ON® ENDOSHEATH®2245012018-07-07
00681490038997N/A13565012017-09-10
00681490040488NA14160002015-06-23
00681490040518NA14160302015-06-23
20681490040604N/A14190202017-10-13
20681490041762NA15140002016-04-30
20681490042424NA15325002015-06-25
20681490069315NA31185302016-04-17
20681490138622BRIDGEMASTER®6003022017-09-09
20681490138646BOOMERANG®6005002017-09-09
20643169232000Alar ™150002017-10-13
00643169553019XPS®1898200TLO2016-05-01
00643169564749VISAO®3334800LO2016-05-01
20613994394525SLIDE-ON®4444012016-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000035433N/AMEDTRONIC XOMED, INC.LTB2021-06-17
00681490070300NAMEDTRONIC XOMED, INC.LTB2016-05-06
00681490023429LesinskiMEDTRONIC XOMED, INC.LTB2016-04-29
00681490023436LesinskiMEDTRONIC XOMED, INC.LTB2016-04-29
00681490023412LesinskiMEDTRONIC XOMED, INC.LTB2016-04-09
00681490035538FischMEDTRONIC XOMED, INC.LTB2016-04-09