FDA.reportPublic FDA data

MEDICOM SAFEMATRIX

Primary DI
20686864056489
Brand
MEDICOM SAFEMATRIX
Company
AMD Medicom Inc
Model
30050
Catalog number
30050
Device description
MEDICOM SAFEMATRIX - MATRIX BAND 4.5 mm Narrow
Published
2021-04-27
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864056489PackageGS18In Commercial Distribution
10686864056482PrimaryGS10
00686864056485Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405648920686864056489
1068686405648210686864056482
00686864056485006868640564856868640564850686864056485

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(514)636-6262mkansou@medicom.ca

Regulatory Flags#

DUNS number
256880576
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864061936MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
10686864061943MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
20686864061933MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
10686864060946MEDICOM DENTICARE 10067100672026-02-25
10686864060953MEDICOM DENTICARE 10068100682026-02-25
20686864060943MEDICOM DENTICARE 10067100672026-02-25
20686864060950MEDICOM DENTICARE 10068100682026-02-25
D8304405061PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514331MEDICOM5514335514332026-02-10
D8304405062PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514332MEDICOM5514335514332026-02-10
D830551432Generic5514322016-10-06
D830551434Generic5514342016-10-06
D830551436Generic5514362016-10-06
D830551438Generic5514382016-10-06
D830551440Generic5514402016-10-06
D830551442Generic5514422016-10-06
D8305604091Tyvek Self-Seal Pouch5604092025-01-02
D830560510Generic5605102016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1380TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1420TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1430TBS BASICSACME ENTERPRISE.JEP2026-05-20
10304040193904Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193911Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193928Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193935Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
20686864061155MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10686864060649MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10686864060656MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10810038090495Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090501Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090518Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090525Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090532Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090549Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090556Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090563Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090492Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090508Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090515Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090522Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090539Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
M752ZZ14080STRADIS HEALTHCARESTRADIS MEDICAL, LLCJEP2022-04-29
10686864056482MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864056499MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10686864057151MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864057168MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10304040142803Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12
10304040142827Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12