FDA.reportPublic FDA data

NeoSmile™

Primary DI
10812594013437
Brand
NeoSmile™
Company
Neotech Products LLC
Model
Hydrogel
Catalog number
N7321
Device description
NeoSmile is intended to cover and secure a temperature probe.
Published
2023-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10812594013437PrimaryGS10
00812594013430Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401343710812594013437
00812594013430008125940134308125940134300812594013430

GMDN Terms#

Term, Definition table
TermDefinition
Electrical cable/lead holderA device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable device.

Regulatory Flags#

DUNS number
198013435
Device count
75
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812594010177NeoBridge®MicoN7002021-05-19
10812594010269NeoBridge®SmallN7012021-05-19
10812594010276NeoBridge®LargeN7022021-05-19
10812594010351EZ-Hold®StandardN7572021-05-19
10812594010726NeoGrip®BlueN602B2021-05-19
10812594010740NeoGrip®Pink & BlueN6022021-05-19
10812594010764NeoGrip®VersaGrip - LargeN6012021-05-19
10812594010788NeoGrip®WhiteN6032021-05-19
10812594011037Hold-A-Line™StandardN7052021-06-02
10812594011358EZ-Hold®MiniN7562021-05-19
10812594011952Telemetry TotesClip-ToteA5012021-06-14
10812594011969Telemetry TotesValu-ToteA5072021-06-14
10812594012096EZ-Hold®Extra LargeN7582021-05-19
10812594012102NeoGrip®RedN602R2021-05-19
10812594012119NeoGrip®Neon GreenN602G2021-05-19
10812594012126NeoGrip®YellowN602Y2021-05-19
10812594012133NeoGrip®OrangeN602O2021-05-19
10812594012140NeoGrip®VioletN602V2021-05-19
10812594012461NeoGrip®PinkN602P2021-05-19
20812594012925NeoSnug Small20812594012925N7015-152023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998041525Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998041556Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998042782Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054129Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054150Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054181Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054211Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054242Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054273Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054327Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054358Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054396Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00194346726660EquateWAL-MART STORES, INC.KGX2026-10-22
00050428344095CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-16
20665973032423DukalDukal LLCKGX2026-10-14
20665973032430DukalDukal LLCKGX2026-10-14
00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30