FDA.reportPublic FDA data

iMed Technology Anchor Dry 12x14

Primary DI
00850010866123
Brand
iMed Technology Anchor Dry 12x14
Company
Imed Technology, Inc.
Model
iMed 12x14
Device description
iMed Anchor Dry 12x14 Master Carton
Published
2024-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010866130PrimaryGS10
00850010866147PrimaryGS10
00850010866123Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010866130008500108661308500108661300850010866130
00850010866147008500108661478500108661470850010866147
00850010866123008500108661238500108661230850010866123

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
087974775
Device count
490
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
10850010866014iMed Technology Anchor Dry 5x5iMed 5x52025-03-25
00850010866017iMed Technology Anchor Dry 5x5iMed 5x52024-12-28
00850010866048iMed Technology Anchor Dry 7x7iMed 7x72024-12-28
00850010866055iMed Technology Anchor Dry 7x7iMed 7x72024-12-28
00850010866079iMed Technology Anchor Dry 9x9iMed 9x92024-12-28
00850010866086iMed Technology Anchor Dry 9x9iMed 9x92024-12-28
00850010866109iMed Technology Anchor Dry 10x12iMed 10x122024-12-28
00850010866116iMed Technology Anchor Dry 10x12iMed 10x122024-12-28
00850010866130iMed Technology Anchor Dry 12x14iMed 12x142024-12-28
00850010866147iMed Technology Anchor Dry 12x14iMed 12x142024-12-28
00850010866000iMed Technology Anchor Dry 5x5iMed 5x52024-12-28
00850010866031iMed Technology Anchor Dry 7x7iMed 7x72024-12-28
00850010866062iMed Technology Anchor Dry 9x9iMed 9x92024-12-28
00850010866093iMed Technology Anchor Dry 10x12iMed 10x122024-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
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
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21
10192253038828KendallCardinal Health 200, LLCNAD2025-11-21
10192253038866KendallCardinal Health 200, LLCNAD2025-11-21
10080196735662MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-15
10080196744121MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-15
10080196744237MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-15
10080196745524MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-15
10080196738526MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-13