NA

Primary DI
00681490070300
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
3152480
Device description
SPRAY 3152480 SILICONE INSTRUMENT
Published
2016-05-06
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
00681490070300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490070300006814900703006814900703000681490070300

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
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000035433N/AMEDTRONIC XOMED, INC.LTB2021-06-17
00643169945395NAMEDTRONIC XOMED, INC.LTB2017-10-16
00681490023429LesinskiMEDTRONIC XOMED, INC.LTB2016-04-29
00681490023436LesinskiMEDTRONIC XOMED, INC.LTB2016-04-29
00681490023412LesinskiMEDTRONIC XOMED, INC.LTB2016-04-09
00681490035538FischMEDTRONIC XOMED, INC.LTB2016-04-09