HCT

Primary DI
00852937003087
Brand
HCT
Company
INNOVATE MEDICAL, LLC
Model
HCT9849-1
Published
2023-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852937003084PackageGS150In Commercial Distribution
00852937003087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085293700308410852937003084
00852937003087008529370030878529370030870852937003087

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050339980
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852937003070HCTHCTBBD-1002023-08-08
00852937003025INNOVATE MEDICAL10-2000-0110-2000-012022-11-14
00852937003032INNOVATE MEDICAL9-204099-204092022-11-14
00852937003049INNOVATE MEDICAL9-204129-204122022-11-14
00852937003056INNOVATE MEDICAL9-206099-206092022-11-14
00852937003063INNOVATE MEDICAL9-206129-206122022-11-14
00852937003278INNOVATE MEDICAL820-5409820-54092022-11-14
00852937003285INNOVATE MEDICAL820-5412820-54122022-11-14
00852937003292INNOVATE MEDICAL820-5609820-56092022-11-14
00852937003308INNOVATE MEDICAL820-5612820-56122022-11-14
00852937003018INNOVATE MEDICAL10-1001-0410-1001-042022-11-14
10852937003022INNOVATE MEDICAL10-2000-0110-2000-012022-11-14
10852937003039INNOVATE MEDICAL9-204099-204092022-11-14
10852937003046INNOVATE MEDICAL9-204129-204122022-11-14
10852937003053INNOVATE MEDICAL9-206099-206092022-11-14
10852937003060INNOVATE MEDICAL9-206129-206122022-11-14
10852937003275INNOVATE MEDICAL820-5409820-54092022-11-14
10852937003282INNOVATE MEDICAL820-5412820-54122022-11-14
10852937003299INNOVATE MEDICAL820-5609820-56092022-11-14
10852937003305INNOVATE MEDICAL820-5612820-56122022-11-14