FDA.reportPublic FDA data

RadStat®

Primary DI
10884450008352
Brand
RadStat®
Company
Merit Medical Systems, Inc.
Model
00884450008355
Catalog number
RADSTD/A
Published
2018-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10884450008352PackageGS120In Commercial Distribution
00884450008355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445000835210884450008352
00884450008355008844500083558844500083550884450008355

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
DM exempt
false
Premarket exempt
true
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
00884450148228Merit Medical®Initial ReleaseK09-09226C2026-08-19
00884450428474Merit Medical®Initial ReleaseK10-04389A2026-08-19
00884450432365Merit Medical®Initial ReleaseK10-05106A2026-08-18
00884450476079CorVocet™BCORA1410S2026-08-18
00884450476093CorVocet™BCORA14152026-08-18
00884450838211Prelude Roadster™APG7F45SX2026-08-18
00884450457535C2 CryoBalloon™AFG-10402026-08-17
00884450458204DuraMax®BH7871030280312026-08-17
00884450531969Prelude Roadster™00884450531969PG6F45S2022-07-20
00884450122471Merit Medical®Initial ReleaseK08-01887B2026-08-14
00884450428245Merit Medical®Initial ReleaseK10-05700A2026-08-15
00884450467220Merit Medical®Initial ReleaseK09-05248N2026-08-14
00884450488775Merit Medical®Initial ReleaseK10T-04423Q2026-08-14
00884450488843Merit Medical®Initial ReleaseK12T-127422026-08-15
00884450110164Merit Disposal Depot™Initial ReleaseK10-00230D2026-08-07
00884450487402Merit Medical®Initial ReleaseK01-083682026-08-07
00884450500859Merit Medical®Initial ReleaseK09-10938D2026-08-08
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00630094049205Bioseal Inc.BIOSEALGAX2024-01-25
00630094049212Bioseal Inc.BIOSEALGAX2024-01-25
00630094049229Bioseal Inc.BIOSEALGAX2024-01-25
00630094049236Bioseal Inc.BIOSEALGAX2024-01-25