FDA.reportPublic FDA data

"ATx Tape 1 1/2"" x 15 Yds 32/cs"

Primary DI
10612553024449
Brand
"ATx Tape 1 1/2"" x 15 Yds 32/cs"
Company
HARTMANN USA, INC.
Model
15700000
Device description
"ATx Tape 1 1/2"" x 15 Yds 32/cs"
Published
2020-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052199525228PackageGS132Not in Commercial Distribution
10612553024449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052199525228040521995252284052199525228
1061255302444910612553024449

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cover adhesive strip, non-antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.

Regulatory Flags#

DUNS number
010137511
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10612553018073Sorbalgon Ag st 2g/30cm P59996092020-09-01
10612553018080Sorbalgon Ag st 15x15cm P59996102020-09-01
10612553018103Sorbalgon Ag st 5x5cm P109996122020-09-01
10612553023480PROXIMEL AG SILICONE DRESSING 3x3 10/BX151000002020-09-01
10612553023497PROXIMEL AG SILICONE DRESSING 4x4 10/BX152000002020-09-01
10612553023503PROXIMEL AG SILICONE DRESSING 6x6 5/BX153000002020-09-01
10612553023510PROXIMEL AG SILICONE DRESSING 4x12 5/BX154000002020-09-01
10612553023527PROXIMEL AG DRESSING SM SACRAL 5/BX155000002020-09-01
10612553018097Sorbalgon Ag st 10x10cm P109996112020-09-01
30612553024290COLACTIVE PLUS 7x7 10/BX103500002020-09-01
00612553000002CollaSorb 1g Powder9060039060032024-03-20
30612553024276ColActive Plus 2x2101600002020-09-01
30612553024283ColActive Plus 4x4101800002020-09-01
30612553024306ColActive Plus AG 2x2 600/cs103300002020-09-01
30612553024313ColActive Plus AG 4x4 300/cs103400002020-09-01
30612553024320COLACTIVE PLUS AG 7x7 10/BX103200002020-09-01
10612553015409STERILUX GZ SPONGE ST 2X2 8PLY 3000/CS568800002020-09-01
10612553015430STERILUX GZ SPONGE ST 4X4 12PLY 1200/CS569100002020-09-01
20612553015642ECONOLUX GZ NS 2X2 8PLY 5000/CS 14,5tex157000002020-09-01
20612553015666ECONOLUX GZ NS 4X4 8PLY 14,5tex 4000/CS4168162020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20