FDA.reportPublic FDA data

SurgiMac

Primary DI
D105SKUMIR04CS0
Brand
SurgiMac
Company
Surgimac LLC
Model
MIR04-CS
Catalog number
MIR04-CS
Device description
#4 Mirrors, Cone Socket F/S, 12/PK.
Published
2024-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D105SKUMIR04CS1PackageHIBCC100In Commercial Distribution
D105SKUMIR04CS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

Regulatory Flags#

DUNS number
060635048
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D105VP9008MI10MacImpress VP-9008-MI-12025-11-07
D105VP9007MI2MacImpress VP-9007-MI2025-09-25
D105VP9011MI2MacImpress VP-9011-MI2025-09-25
D105VP9007MI11MacImpress VP-9007-MI-12025-09-25
D105VP9007MI21MacImpress VP-9007-MI2025-09-25
D105VP9011MI11MacImpress VP-9011-MI-12025-09-25
D105VP9011MI21MacImpress VP-9011-MI2025-09-25
D105121781MacBite121782025-08-15
D1051217840MacBite12178-42025-08-15
D105121789MacBite121782025-08-15
D1051217849MacBite12178-42025-08-15
D1057115XS0MacTouch 7115-XS2025-08-14
D1057115XSCS1MacTouch 7115-XS-CS2025-08-14
D1057116S0MacTouch 7116-S2025-08-14
D1057116SCS1MacTouch 7116-S-CS2025-08-14
D1057117M0MacTouch 7117-M2025-08-14
D1057117MCS1MacTouch 7117-M-CS2025-08-14
D1057118L0MacTouch 7118-L2025-08-14
D1057118LCS1MacTouch 7118-L-CS2025-08-14
D1057119XL0MacTouch 7119-XL2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10818207024227Vista OCS Mirror HandleVista DentalEAX2022-09-01
10843717102592Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102608Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102615Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102622Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
G1577072350PomeePOMEE CORPORATIONEAX2021-12-30
10889950015381HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015398HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015404HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015411HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015428HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015435HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015442HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015459HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015466HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12