FDA.reportPublic FDA data

HCS

Primary DI
10849027002003
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS1008A
Device description
16” Proctoscopic Rayon Tip Applicator w/Plastic Shaft
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10849027002003PackageGS110In Commercial Distribution
00849027002006PrimaryGS10
20849027002000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084902700200310849027002003
00849027002006008490270020068490270020060849027002006
2084902700200020849027002000

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 made of wood, paper, or plastic, 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 to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is used in a healthcare setting and in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078572603
Device count
50
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849027004694HCSHCS5025TS2020-11-16
00849027004703HCSHCS5035TS2020-11-16
10849027004717HCSHCS5045TS2020-11-16
10849027004724HCSHCS5065TS2020-11-16
10849027005103HCSHCS3013BK2021-10-19
10849027005134HCS3001BU2021-05-07
10849027005141HCS3001BXL2021-05-07
10849027004656HCSHCS5033-25S2021-01-31
10849027004663HCSHCS5033-35S2021-01-31
10849027004670HCSHCS5033-45S2021-01-31
10849027004687HCSHCS5033-65S2021-01-31
30849027004858HCSHCS02112021-01-31
30849027004865HCSHCS02122021-01-31
30849027004872HCSHCS02132021-01-31
30849027004889HCSHCS02142021-01-31
10849027004946HCSHCS1108HC2021-01-29
10849027005028HCSHCS5033-411LF2021-01-29
10849027005035HCSHCS5033-411S2021-01-31
10849027005042HCSHCS5033-611S2021-01-31
10849027005189HCSHCS11202021-01-31

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