NewGel+ Silicone Gel Sheeting

GUDID 00816465021005

NG-363 NewGel+ Clear Silicone Abdomen Sheet, 2"x18" (5.1x45.7cm), 1 pc/package

Newmedical Technology, Inc.

Scar-management dressing, reusable
Primary Device ID00816465021005
NIH Device Record Keyc4fa8b5c-7219-466e-8bc0-248f25f48e66
Commercial Distribution StatusIn Commercial Distribution
Brand NameNewGel+ Silicone Gel Sheeting
Version Model NumberNG-363
Company DUNS787828669
Company NameNewmedical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816465021005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-15
Device Publish Date2025-08-07

On-Brand Devices [NewGel+ Silicone Gel Sheeting]

00816465021074NG-160 NewGel+ Beige Silicone Abdomen Sheet, 2"x8" (5.1x20.3cm), 2 pcs/package
00816465021067NG-900 NewGel+ Silicone Belly Button, 0.54" dia. (1.4cm dia.), 1 pc/package
00816465021050NG-180 NewGel+ Beige Silicone Dots, 1" dia. (2.5cm dia.), 6 pcs/package
00816465021043NG-370 NewGel+ Clear Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package
00816465021036NG-170 NewGel+ Beige Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package
00816465021029NG-364 NewGel+ Clear Silicone Abdomen Sheet, 2"x24" (5.1x.61.0cm), 1 pc/package
00816465021012NG-164 NewGel+ Beige Silicone Abdomen Sheet, 2"x24" (5.1x61.0cm), 1 pc/package
00816465021005NG-363 NewGel+ Clear Silicone Abdomen Sheet, 2"x18" (5.1x45.7cm), 1 pc/package
00816465020992NG-163 NewGel+ Beige Silicone Abdomen Sheet, 2"x18" (5.1x45.7cm), 1 pc/package
00816465020985NG-360 NewGel+ Clear Silicone Abdomen Sheet, 2"x8" (5.1 x20.3tm), 2 pcs/package
00816465020954NG-328 NewGel+ Clear Silicone Breast Kit, 2 pcs Areola & 2 pcs Anchor/package
00816465020947NG-128 NewGel+ Beige Silicone Breast Kit, 2 pcs Areolas & 2 pcs Anchors/package
00816465020930NG-326 NewGel+ Clear Silicone Anchor, 10"x4 1/8" (25.4x10.5cm), 2 pcs/package
00816465020923NG-126 NewGel+ Beige Silicone Anchor, 10"x4 1/8" (25.4x10.5cm), 2 pcs/package
00816465020916NG-324 NewGel+ Clear Silicone Lollypop, 2 7/8"x6 1/2" (7.2x16.4cm), 2 pcs/package
00816465020909NG-124 NewGel+ Beige Silicone Lollypop, 2 7/8"x6 1/2" (7.2x16.4cm), 2 pcs/package
00816465020893NG-120 NewGel+ Beige Silicone Areola, 2 7/8" dia. (7.2cm dia.), 2 pcs/package
00816465020886NG-101S NewGel+ Beige Silicone Strips, 1"x6" (2.5x15.2cm), 4 pcs/package
00816465020879NG-101 NewGel+ Beige Silicone Sheet, 5"x6" (12.7x15.2cm), 1 pc/package
00816465020862NG-30133 NewGel+ Clear Silicone Strips, 1"x3" (2.5x7.6cm), 3 pcs/package
00816465020855NG-301S2 NewGel+ Clear Silicone Strips, 1"x6" (2.5x15.2cm), 2 pcs/package
00816465020848NG-301S1 NewGel+ Clear Silicone Strip, 1"x6" (2.5x15.2cm), 1 pc/package
00816465020350NG-320 NewGel+ Clear Silicone Areola, 2 7/8" dia. (7.2cm dia.), 2 pcs/package
00816465020343NG-380 NewGel+ Clear Silicone Dots, 1" dia. (2.5cm dia.), 6 pcs/package
00816465020336NG-301S NewGel+ Clear Silicone Strips, 1"x6" (2.5x.15.2cm), 4 pcs/package
00816465020329NG-301 NewGel+ Clear Silicone Sheet, 5"x6" (12.7x15.2cm), 1 pc/package
00816465020015NG-165 NewGel+ Beige Silicone Abdomen Sheet, 2"x8"(5.1 x20.3cm), 1 pc/package
00816465020008NG-365 NewGel+ Clear Silicone Abdomen Sheet, 2"x8" (5.1 x20.3cm), 1 pc/package

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