SCOUT

Primary DI
10705034753799
Brand
SCOUT
Company
SYNTHES (U.S.A.) LP
Model
08.650.101S
Catalog number
08650101S
Device description
SCOUT VESSEL GUARD 65MM X 55MM X 1MM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMRVessel guard or cover

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMRVessel Guard Or CoverCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103558000SYNTHES SCOUT VESSEL GUARDSynthes Spine2011-02-18OMR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034753799PrimaryGS10
H98108650101S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503475379910705034753799

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, syntheticAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982027795NA02.007.000S02007000S2015-09-14
10886982066763NA03.007.020030070202016-12-31
10886982160898NA237.043S237043S2015-09-14
10886982160904NA237.044S237044S2015-09-14
10886982160928NA237.054S237054S2015-09-14
10886982160935NA237.063S237063S2015-09-14
10886982160942NA237.064S237064S2015-09-14
10886982160959NA237.083S237083S2015-09-14
10886982160966NA237.084S237084S2015-09-14
10886982160973NA237.085S237085S2015-09-14
10886982160980NA237.086S237086S2015-09-14
10886982161000NA237.104S237104S2015-09-14
10886982161017NA237.105S237105S2015-09-14
10886982161024NA237.106S237106S2015-09-14
10886982161031NA237.123S237123S2015-09-14
10886982161048NA237.124S237124S2015-09-14
10886982161055NA237.125S237125S2015-09-14
10886982162038LCP238.7002387002015-09-14
10886982162052LCP238.7012387012015-09-14
10886982162076LCP238.7022387022015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D132MG0010Oral-B Nighttime Dental GuardOralabs, LLCOMR2023-08-04
10705034753805SCOUTSYNTHES (U.S.A.) LPOMR2015-09-14
H98108650101S0SCOUTSYNTHES (U.S.A.) LPOMR2015-09-14
H98108650102S0SCOUTSYNTHES (U.S.A.) LPOMR2015-09-14