FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450146354
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450146354
Catalog number
K13-00749D
Published
2018-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYBMinor surgical procedures tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450146351PackageGS125In Commercial Distribution
20884450146358PackageGS14In Commercial Distribution
00884450146354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445014635110884450146351
2088445014635820884450146358
00884450146354008844501463548844501463540884450146354

GMDN Terms#

Term, Definition table
TermDefinition
Procedural medication labelling setA collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02
00884450467183Merit Medical®Initial ReleaseK10T-06193A2026-06-02
00884450474549Merit Medical®Initial ReleaseK09-134782026-06-02
00884450474556Merit Medical®Initial ReleaseK09-134792026-06-02
00884450474563Merit Medical®Initial ReleaseK09-136162026-06-02
00884450589977SplashWire™Initial ReleaseMSWSTFA35150LT2026-06-02
00884450794760DuraMax®AH7871030290412026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844107000736Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000750Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000781Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000828Arbutus MedicalArbutus Medical IncPYB2026-04-28
00884450116913Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
00884450096529Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
00884450089897Merit Medical®Merit Medical Systems, Inc.PYB2025-05-20
00840365908623InvenioGri-Alleset, Inc.PYB2025-03-12
00884450185261Merit Medical®Merit Medical Systems, Inc.PYB2023-01-04
M7526821425R10STRADIS HEALTHCARESTRADIS MEDICAL, LLCPYB2022-12-22
10197106029916CARDINAL HEALTHCardinal Health 200, LLCPYB2022-11-18
H65857031545Henry ScheinHENRY SCHEIN, INC.PYB2022-08-25
H65857030875Henry ScheinHENRY SCHEIN, INC.PYB2022-05-25
00884450187494Merit Medical®Merit Medical Systems, Inc.PYB2021-10-28
00844107000637Arbutus MedicalArbutus Medical IncPYB2021-10-19
00884450186428Merit Medical®Merit Medical Systems, Inc.PYB2021-03-03
00884450248805Merit Medical®Merit Medical Systems, Inc.PYB2019-10-31
00884450055144PAL™Merit Medical Systems, Inc.PYB2018-09-17
00884450166062Merit Medical®Merit Medical Systems, Inc.PYB2018-09-17
00884450049556Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049570Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049587Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049594Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049617Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053799Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053805Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053836Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450055120Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450055137Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450143865Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14