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
10705034711874ATB03.601.110036011102016-12-31
10705034711881ATB03.601.111036011112016-12-31
10705034711898ATB03.601.112036011122016-12-31
10705034711904ATB03.601.113036011132016-12-31
10705034711911ATB03.601.114036011142016-12-31
10705034711928ATB03.601.115036011152016-12-31
10705034711935ATB03.601.116036011162016-12-31
10705034711942ATB03.601.117036011172016-12-31
10705034711959ATB03.601.118036011182016-12-31
10705034711966ATB03.601.140036011402016-12-31
10705034711973ATB03.601.142036011422016-12-31
10705034711980ATB03.601.144036011442016-12-31
10705034711997ATB03.601.146036011462016-12-31
10705034712000ATB03.601.148036011482016-12-31
10705034712017ATB03.601.150036011502016-12-31
10705034712024ATB03.601.152036011522016-12-31
10705034712031ATB03.601.154036011542016-12-31
10705034712048ATB03.601.156036011562016-12-31
10705034712055ATB03.601.170036011702016-12-31
10705034712062ATB03.601.172036011722016-12-31

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