FDA.reportPublic FDA data

WRAPSODY®

Primary DI
00884450845394
Brand
WRAPSODY®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
WRAP-L06100
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00884450845394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450845394008844508453948844508453940884450845394

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450845820WRAPSODY®Merit Medical Systems, Inc.PFV2026-06-24
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
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