FDA.reportPublic FDA data

GUM®

Primary DI
10070942752302
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
706
Catalog number
PQ
Device description
MOUTH MIRROR
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070942752302PackageGS112In Commercial Distribution
00070942752305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007094275230210070942752302
00070942752305000709427523050709427523050070942752305

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)777-3101contact.us@us.sunstar.com

Regulatory Flags#

DUNS number
025066358
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942008334GUM®875SM2026-07-28
00070942005265GUM®3615BQ2023-01-26
00070942006491GUM®3615PQA2023-12-07
00070942005425GUM®4100UTWA2023-06-14
00070942005432GUM®4100UTBA2023-06-14
00070942008822GUM® Expanding Floss2030R42026-05-01
00070942008952GUM® Professional Clean Floss1820RA2026-04-30
00070942783354GUM®9934RA2024-03-12
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS853PA2025-11-04
00070942007368GUM Technique Sensitive Clean527TPA12025-08-15
00070942007412GUM Technique Sensitive Clean527TRA22025-08-15
00070942008099GUM Technique Sensitive Clean527CNL2025-08-15
10070942007365GUM Technique Sensitive Clean527TPA12025-08-15
10070942007419GUM Technique Sensitive Clean527TRA22025-08-15
20070942008093GUM Technique Sensitive Clean527CNL2025-08-15
00070942008112GUM Technique Deep Clean5255252025-05-19
00070942006378GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
00070942008105GUM Technique Sensitive Clean524CNL524CNL2025-05-19
20070942006372GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
20070942008109GUM Technique Sensitive Clean524CNL524CNL2025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955MM5CSFS1Paul BandittTerlain Enterprises, Inc.EAX2026-09-25
G879MMFS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
00840456218341JMUJMU DENTAL, INCEAX2026-07-07
00840456218358JMUJMU DENTAL, INCEAX2026-07-07
00840456218365JMUJMU DENTAL, INCEAX2026-07-07
00840456218372JMUJMU DENTAL, INCEAX2026-07-07
00840456218389JMUJMU DENTAL, INCEAX2026-07-07
00840456218396JMUJMU DENTAL, INCEAX2026-07-07
08961104622579Dental Mouth Mirror MELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622586Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622944Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
G149TBSB3110TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3120TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3130TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3140TBS BASICSACME ENTERPRISE.EAX2026-05-16
1081000052669420/20™PARKELL, INC.EAX2025-09-26
M633680501B4JEDMEDJEDMED INSTRUMENT COMPANYEAX2023-02-03
10371347002550Mirror Front Surface Cone Socket #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002567Mirror Front Surface Simple Stem #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002574Mirror Front Surface Cone Socket #5The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002581Mirror Front Surface Simple Stem #5The Atlanta Dental Supply CompanyEAX2022-11-23
10818207024203Vista RSS Mirror HandleVista DentalEAX2022-09-01
10818207024210Vista RCS Mirror HandleVista DentalEAX2022-09-01