FDA.reportPublic FDA data

WRAPSODY®

Primary DI
00884450845820
Brand
WRAPSODY®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
WRAP-S06125
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PFVSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450845820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450845820008844508458208844508458200884450845820

GMDN Terms#

Term, Definition table
TermDefinition
Central/peripheral venous endovascular stent-graftA non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450845400WRAPSODY®Merit Medical Systems, Inc.PFV2026-05-05
00884450845561WRAPSODY®Merit Medical Systems, Inc.PFV2026-04-21
00884450845387WRAPSODY®Merit Medical Systems, Inc.PFV2026-02-14
00884450845851WRAPSODY®Merit Medical Systems, Inc.PFV2025-12-16
00884450845813WRAPSODY®Merit Medical Systems, Inc.PFV2025-10-07
00884450845608WRAPSODY®Merit Medical Systems, Inc.PFV2025-08-08
00884450845806WRAPSODY®Merit Medical Systems, Inc.PFV2025-07-01
00884450845844WRAPSODY®Merit Medical Systems, Inc.PFV2025-06-18
00884450845615WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-24
00884450845905WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-24
00884450845417WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-15
00884450845790WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-15
00884450845394WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-14
00884450845653WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845691WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845714WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845639WRAPSODY®Merit Medical Systems, Inc.PFV2025-04-21
00884450845660WRAPSODY®Merit Medical Systems, Inc.PFV2025-04-18
00884450845462WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-22
00884450845622WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-22
00884450845684WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-15
00884450845950WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-08
00884450845967WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-08
00884450845646WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-04
00884450845738WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-21
00884450845516WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-12
00884450845677WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-12
00884450845776WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-06
00884450845899WRAPSODY®Merit Medical Systems, Inc.PFV2025-01-30
00884450845752WRAPSODY®Merit Medical Systems, Inc.PFV2025-01-29