FDA.reportPublic FDA data

RadStat®

Primary DI
00884450008348
Brand
RadStat®
Company
Merit Medical Systems, Inc.
Model
00884450008348
Catalog number
RADSRT/A
Published
2018-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GAXTOURNIQUET, NONPNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450008348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450008348008844500083488844500083480884450008348

GMDN Terms#

Term, Definition table
TermDefinition
Vascular compressor, externalA thin, gently curved sheet of radiolucent plastic used for external compression of the internal spermatic vein to prevent distal flow of a sclerosing agent. The device is also used in the compression of additional veins, bypass grafts, and fistulas during angiographic procedures. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450735916Merit Advance®AAD18N91W-E2026-10-19
10884450735906Merit Advance®AAD18N91W2026-10-19
10884450735920Merit Advance®AAD18T51W2026-10-19
10884450735944Merit Advance®AAD18T51WS2026-10-19
10884450735968Merit Advance®AAD18T71W2026-10-19
10884450735975Merit Advance®AAD18T71WC2026-10-19
10884450735999Merit Advance®AAD18T71W-E2026-10-19
10884450736033Merit Advance®AAD18T71WS2026-10-19
10884450736057Merit Advance®BAD18T71WT2026-10-19
10884450736071Merit Advance®AAD19U41W2026-10-19
10884450736118Merit Advance®AAD19U51W2026-10-19
10884450736132Merit Advance®AAD19U71W2026-10-19
10884450736149Merit Advance®AAD19U71WC2026-10-19
10884450736187Merit Advance®AAD19U71WS2026-10-19
10884450736224Merit Advance®AAD20T41W2026-10-19
10884450736262Merit Advance®AAD20T71W2026-10-19
10884450736309Merit Advance®AAD21T21W2026-10-19
10884450736361Merit Advance®AAD21T41WC2026-10-19
10884450736385Merit Advance®AAD21T41W-E2026-10-19
10884450736439Merit Advance®AAD21T71W2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061187185EVERLITEverlit Global Inc.GAX2026-09-28
00850061187192EVERLITEverlit Global Inc.GAX2026-09-28
00850061187208EVERLITEverlit Global Inc.GAX2026-09-28
00850061187215EVERLITEverlit Global Inc.GAX2026-09-28
00199536932005BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932012BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932029BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932036BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932043BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932050BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932067BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
40884389110493MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-07-03
40888277362261MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-06-09
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
00842942010897PRIMEDpriMED Medical Products IncGAX2026-03-03
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
05060483571867TMT (Tactical Mechanical Tourniquet)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDGAX2024-10-02
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
00630094049182Bioseal Inc.BIOSEALGAX2024-01-25
00630094049199Bioseal Inc.BIOSEALGAX2024-01-25