FDA.reportPublic FDA data

Safety Paracentesis Procedure Tray

Primary DI
00884450277638
Brand
Safety Paracentesis Procedure Tray
Company
Merit Medical Systems, Inc.
Model
00884450277638
Catalog number
SPPT-6F-7S
Published
2018-09-13
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
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450277635PackageGS15In Commercial Distribution
00884450277638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445027763510884450277635
00884450277638008844502776388844502776380884450277638

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
603160040
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22
00884450421581Merit Medical®Initial ReleaseK12-08733A2026-07-21
00884450795705Merit Medical®Initial ReleaseK12-10248A2026-07-21
00884450457382C2 CryoBalloon™AFG-10132026-07-20
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14

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Primary DI, Brand, Company table
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