FDA.reportPublic FDA data

Micro-Tip

Primary DI
00854623006075
Brand
Micro-Tip
Company
Solstice Corporation
Model
A28PC
Catalog number
A28PC
Device description
miniature non-sterile cotton tip applicators, 200 count, 2.8mm x 6in
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00854623006075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854623006075008546230060758546230060750854623006075

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-874-7922info@solsticecorp.com

Regulatory Flags#

DUNS number
609823877
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854623006006XactM15SM15S2021-02-26
00854623006013XactM10TTM10TT2021-02-26
00854623006020XactM23SCM23SC2021-02-26
00854623006037XactM10LMM10LM2021-02-26
00854623006051XactM15RTM15RT2021-02-26
00854623006068XactM15RMM15RM2021-02-26
00854623006082XactM20SM20S2021-02-26
00854623006099XactM15SCM15SC2021-02-26
00854623006105XactM20SCM20SC2021-02-26
00854623006112XactM10TMM10TM2021-02-26
00854623006129XactM10RM10R2021-02-26
00854623006136XactM15RM15R2021-02-26
00854623006143XactM10ACM10AC2021-02-26
10854623006003XactM15SM15S2021-02-26
10854623006010XactM10TTM10TT2021-02-26
10854623006027XactM23SCM23SC2021-02-26
10854623006034XactM10LMM10LM2021-02-26
10854623006058XactM15RTM15RT2021-02-26
10854623006065XactM15RMM15RM2021-02-26
10854623006089XactM20SM20S2021-02-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10609576331098Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331111Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331418Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331432Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331449Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331586Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576340007Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360203Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360210Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360241Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360265Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576800068Puritan®Puritan Medical ProductsKXF2026-07-20
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30609576800208Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800406Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800543Puritan®Puritan Medical ProductsKXF2026-07-20
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