RenoCare Spot

GUDID 08800048007731

RenoCareTM Hydrocolloid Band has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a breathable polyurethane film backing. Hydrocolloid matrix rapidly absorbs exudates to form a cohesive gel providing significantly higher absorbency than the leading competitive hydrocolloid. In addition to excellent absorbency, the breathable polyurethane film backing provides a consistently high rate of moisture vapor transmission. Together, these features ensure an optimal moist wound environment, minimize the chance for damage to healthy peri-wound skin and provide cost-effective wear time for up to seven days.

T&L Co.,Ltd.

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID08800048007731
NIH Device Record Key2e813211-03f5-4827-a9ba-5125e33d9393
Commercial Distribution StatusIn Commercial Distribution
Brand NameRenoCare Spot
Version Model NumberHD14EN46
Company DUNS694747496
Company NameT&L Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800048007731 [Primary]

FDA Product Code

NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-18
Device Publish Date2021-02-10

Devices Manufactured by T&L Co.,Ltd.

08800048000008 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre
08800048000015 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre
08800048000022 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre
08800048000039 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre
08800048000046 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre
08800048000053 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre
08800048000060 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre
08800048000077 - Suprasorb H2021-02-18 Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a bre

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