FDA.reportPublic FDA data

SunMed

Primary DI
10889483007563
Brand
SunMed
Company
SUNMED, LLC
Model
9-3041-03
Catalog number
9-3041-03
Device description
DISP TOOTH PROTECTOR PK/50
Published
2024-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10889483007563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948300756310889483007563

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
+1(800)433-2797info@myairlife.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483564523BALLARD™227013522701352025-11-19
10889483564585BALLARD™22705227052025-11-18
10889483564615BALLARD™227101-5227101-52025-11-20
10889483564622BALLARD™2271018-52271018-52025-11-20
10889483564653BALLARD™2271218-52271218-52025-11-20
10889483564721BALLARD™22714183-522714183-52025-11-20
10889483564738BALLARD™2271418-52271418-52025-11-20
10889483564837BALLARD™2271613-52271613-52025-11-20
10889483564844BALLARD™227161-5227161-52025-11-20
10889483564868BALLARD™2271618-52271618-52025-11-20
10889483623527BALLARD™2271053-52271053-52025-11-20
10889483623534BALLARD™227105-5227105-52025-11-20
10889483623589BALLARD™2271616-52271616-52025-11-20
10889483564769BALLARD™22714186-522714186-52025-11-19
10889483564134BALLARD™216-5216-52026-07-09
10889483563113BALLARD™11000110002025-12-01
10889483007051SunMed9-0207-019-0207-012024-03-12
10889483007068SunMed9-0207-039-0207-032024-03-12
10889483564325BALLARD™2210-52210-52025-11-20
10889483623411BALLARD™22056-522056-52025-11-20

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
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
00630094199016Bioseal Inc.BIOSEALBRW2023-12-07