FDA.reportPublic FDA data

LEVINE IRRIGATION-SUCTION TUBING

Primary DI
00850000126152
Brand
LEVINE IRRIGATION-SUCTION TUBING
Company
Oto-Med, Inc.
Model
SP-3000
Device description
LEVINE IRRIGATION-SUCTION TUBING
Published
2021-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850000126159PackageGS16In Commercial Distribution
00850000126152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000012615910850000126159
00850000126152008500001261528500001261520850000126152

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
059817742
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000126077spineX BONE DUST COLLECTORS-45002018-09-21
00850000126169CI UNIVERSAL DRAPESD-23002021-11-19
00850000126084GLASSCOCK OTOLOGY SURGERY DRAPESD-21002018-09-21
00850000126091GLASSCOCK NEUROTOLOGY SURGERY DRAPESD-22002018-09-21
10850000126166CI UNIVERSAL DRAPESD-23002021-11-19
00850000126121OTOMED® SUCTION TUBINGSP-40002018-09-21
10850000126159LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
00850000126015GLASSCOCK® EAR DRESSING, ADULTS-10002018-09-21
00850000126022GLASSCOCK® EAR DRESSING, PEDIATRICS-10032018-09-21
00850000126046SHEEHY BONE DUST COLLECTORS-25002018-09-21
00850000126060COX BONE DUST COLLECTORS-35002018-09-21
00850000126138EAR DRESSING, ADULTS-10002020-11-30
00850000126145EAR DRESSING, PEDIATRICS-10032020-11-30
10850000126135EAR DRESSING, ADULTS-10002020-11-30
10850000126142EAR DRESSING, PEDIATRICS-10032020-11-30
00850000126039HEAD & NECK PRESSURE DRESSINGS-1010-22018-09-21
00850000126114LEVINE IRRIGATION-SUCTION KITSP-30002018-09-21
00850000126053SHEEHY-HOUSE POWDER INSUFFLATORS-30012018-09-21
00850000126107SAFETRAP TISSUE COLLECTORSP-20002018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450022146One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022160One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022184One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022306One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022313One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022535One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022559One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022566One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022573One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022597One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022603One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022665One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022689One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022764One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024010One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024027One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00840456202692JMUJMU DENTAL, INCGBX2026-07-27
00840456202708JMUJMU DENTAL, INCGBX2026-07-27
00884450014523ReSolve®, StayFIX®,Merit Medical Systems, Inc.GBX2026-07-16
00840456216750JMUJMU DENTAL, INCGBX2026-06-22
00840456216767JMUJMU DENTAL, INCGBX2026-06-22
00840456216774JMUJMU DENTAL, INCGBX2026-06-22
17350128050006LinkUS DrainInterlinked ABGBX2026-05-31
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07