FDA.reportPublic FDA data

NAZORCAP Bite Guard

Primary DI
00856824006083
Brand
NAZORCAP Bite Guard
Company
Nasorcap Medical, Inc.
Model
1801
Device description
Bite Guard/Tubing Protector
Published
2018-03-25
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
BRWProtector, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856824006080PackageGS150In Commercial Distribution
00856824006083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085682400608010856824006080
00856824006083008568240060838568240060830856824006083

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, single-useA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
412-466-1412nasorcap@yahoo.com

Regulatory Flags#

DUNS number
803689769
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856824006014NAZORCAP SamplerModel No. 9112-T/FB2016-02-08
00856824006038NAZORCAP SamplerModel No. 9801-FB2016-02-08
00856824006052NAZORCAP SamplerModel No. 9801-FBL2016-02-08
00856824006069NAZORCAP SamplerModel No. 9801-F42016-02-08
00856824006106AirWave0802-M2018-01-18
00856824006113AirWave0802-L2018-01-18
00856824006137NAZORCAP SamplerModel No. 9801-M42017-01-12
00856824006007NAZORCAP SamplerModel No. 9112-T2016-02-08
00856824006021NAZORCAP SamplerModel No. 9801-F2016-02-08
00856824006045NAZORCAP SamplerModel No. 9801-MB2016-02-08
00856824006090AirWave0802-S2018-01-18
00856824006182ENDOCAP Bite Block17092018-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676748188Endoragard teeth protectorSpiggle & Theis Medizintechnik GmbHBRW2026-04-27
08800017902289EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017901817EZ Bite blockDXM CO., LTDBRW2025-12-16
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797099365RMORmo, Inc.BRW2024-09-02
00885797099372RMORmo, Inc.BRW2024-09-02
00885797099396RMORmo, Inc.BRW2024-09-02
00885797099402RMORmo, Inc.BRW2024-09-02
00885797672278RMORmo, Inc.BRW2024-08-26
00885797672292RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
00630094199702Bioseal Inc.BIOSEALBRW2023-12-12
10630094199709Bioseal Inc.BIOSEALBRW2023-12-12
00630094199207Bioseal Inc.BIOSEALBRW2023-12-11
00630094199252Bioseal Inc.BIOSEALBRW2023-12-11
00630094199306Bioseal Inc.BIOSEALBRW2023-12-11
00630094199320Bioseal Inc.BIOSEALBRW2023-12-11
10630094199204Bioseal Inc.BIOSEALBRW2023-12-11
10630094199259Bioseal Inc.BIOSEALBRW2023-12-11
10630094199303Bioseal Inc.BIOSEALBRW2023-12-11
10630094199327Bioseal Inc.BIOSEALBRW2023-12-11