FDA.report

Merit Medical®

Primary DI
20884450291997
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450291993
Catalog number
K13-03501A
Published
2018-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PYBMinor surgical procedures tray

Product Code Classifications

CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450291990PackageGS125In Commercial Distribution
20884450291997PackageGS14In Commercial Distribution
00884450291993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445029199010884450291990
2088445029199720884450291997
00884450291993008844502919938844502919930884450291993

GMDN Terms

TermDefinition
Procedural medication labelling setA collection of sterile 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20884450376335Merit Medical®Merit Medical Systems, Inc.PYB2026-02-14
10884450116910Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
10884450096526Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
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05010058182790InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
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05010058182974InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
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05010058184992InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-22
05010058178229InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-21
05010058178427InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-21