FDA.reportPublic FDA data

Safety Paracentesis Procedure Tray

Primary DI
00884450277652
Brand
Safety Paracentesis Procedure Tray
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
SPPT-8F-10S
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYCParacentesis tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYCParacentesis TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450277659PackageGS15In Commercial Distribution
00884450277652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445027765910884450277659
00884450277652008844502776528844502776520884450277652

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
00884450113059Merit Medical®Initial ReleaseK09-13911C2026-10-20
00884450840610Prelude Roadster™APG5F90S2026-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956489035CARDINAL HEALTHCardinal Health 200, LLCPYC2026-06-05
10198956454835CARDINAL HEALTHCardinal Health 200, LLCPYC2026-05-08
10198956400351CARDINAL HEALTHCardinal Health 200, LLCPYC2026-03-06
50198956400359CARDINAL HEALTHCardinal Health 200, LLCPYC2026-03-06
10198956303607CARDINAL HEALTHCardinal Health 200, LLCPYC2026-01-13
50198956303605CARDINAL HEALTHCardinal Health 200, LLCPYC2026-01-13
10198956196452CARDINAL HEALTHCardinal Health 200, LLCPYC2025-11-21
10198956223318CARDINAL HEALTHCardinal Health 200, LLCPYC2025-11-07
10198956179677CARDINAL HEALTHCardinal Health 200, LLCPYC2025-08-27
50198956179675CARDINAL HEALTHCardinal Health 200, LLCPYC2025-08-27
10198956100251CARDINAL HEALTHCardinal Health 200, LLCPYC2025-07-15
50198956100259CARDINAL HEALTHCardinal Health 200, LLCPYC2025-07-15
10198956082342CARDINAL HEALTHCardinal Health 200, LLCPYC2025-06-09
50198956082340CARDINAL HEALTHCardinal Health 200, LLCPYC2025-06-09
10198956056121CARDINAL HEALTHCardinal Health 200, LLCPYC2025-05-07
50198956056129CARDINAL HEALTHCardinal Health 200, LLCPYC2025-05-07
10197106886809CARDINAL HEALTHCardinal Health 200, LLCPYC2025-04-07
50197106886807CARDINAL HEALTHCardinal Health 200, LLCPYC2025-04-07
10197106914205CARDINAL HEALTHCardinal Health 200, LLCPYC2025-02-17
50197106914203CARDINAL HEALTHCardinal Health 200, LLCPYC2025-02-17
10197106881606CARDINAL HEALTHCardinal Health 200, LLCPYC2025-01-21
50197106881604CARDINAL HEALTHCardinal Health 200, LLCPYC2025-01-21
00884450809310Merit Medical®Merit Medical Systems, Inc.PYC2024-12-28
10884450809317Merit Medical®Merit Medical Systems, Inc.PYC2024-12-28
10197106793305CARDINAL HEALTHCardinal Health 200, LLCPYC2024-12-12
50197106793303CARDINAL HEALTHCardinal Health 200, LLCPYC2024-12-12
10197106471746CARDINAL HEALTHCardinal Health 200, LLCPYC2024-04-26
50197106471744CARDINAL HEALTHCardinal Health 200, LLCPYC2024-04-26
10197106569948CARDINAL HEALTHCardinal Health 200, LLCPYC2024-02-12
50197106569946CARDINAL HEALTHCardinal Health 200, LLCPYC2024-02-12