FDA.reportPublic FDA data

Sterling Healthcare Manufacturing

Primary DI
00860005875504
Brand
Sterling Healthcare Manufacturing
Company
The Rodon Group
Model
4026
Device description
Sterling Fluid Trap-Tip Swabs, Sterile, Standard Stem
Published
2022-09-21
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

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860005875501PackageGS1500In Commercial Distribution
20860005875508PackageGS16In Commercial Distribution
00860005875504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000587550110860005875501
2086000587550820860005875508
00860005875504008600058755048600058755040860005875504

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824635127
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005875511Sterling Healthcare Manufacturing40272022-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
57613327680756Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
30889483563278BALLARD™SUNMED, LLCKXF2025-11-17
30889483563292BALLARD™SUNMED, LLCKXF2025-11-17
10889483563304BALLARD™SUNMED, LLCKXF2025-11-17
30889483563322BALLARD™SUNMED, LLCKXF2025-11-17
30889483563346BALLARD™SUNMED, LLCKXF2025-11-17
30889483565524BALLARD™SUNMED, LLCKXF2025-11-17
30889483565531BALLARD™SUNMED, LLCKXF2025-11-17
30889483565548BALLARD™SUNMED, LLCKXF2025-11-17
M220761003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BR4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BSF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
00840456214893JMUJMU DENTAL, INCKXF2025-07-15
00840456214909JMUJMU DENTAL, INCKXF2025-07-15
00840456214930JMUJMU DENTAL, INCKXF2025-07-15
00840456209127JMUJMU DENTAL, INCKXF2025-06-17
00840456209134JMUJMU DENTAL, INCKXF2025-06-17
00840456209141JMUJMU DENTAL, INCKXF2025-06-17
00840456213742JMUJMU DENTAL, INCKXF2025-06-17
00840456213759JMUJMU DENTAL, INCKXF2025-06-17
00840456213766JMUJMU DENTAL, INCKXF2025-06-17
00840456213773JMUJMU DENTAL, INCKXF2025-06-17
00840456213780JMUJMU DENTAL, INCKXF2025-06-17
00840456213797JMUJMU DENTAL, INCKXF2025-06-17
00848253004037StomaSoft Cleaning SwabsFreudenberg Medical, LLCKXF2025-03-17
00854498007047SmartPracticeSmarthealth, Inc.KXF2025-02-17
30840330701458ProCureTwin Med, LLCKXF2024-11-14
30840330701465ProCureTwin Med, LLCKXF2024-11-14