FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780380405
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
RFAC1
Catalog number
RFAC1
Device description
Condenser, Amalgam, Acorde 1, Double-Ended, Round Handle
Published
2018-04-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780380405PrimaryGS10
H834RFAC10SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178038040510381780380405

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam condenser, reusableA hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB4170TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4180TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4190TBS BASICSACME ENTERPRISE.EKG2026-05-20
00348783012323Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKG2026-04-30
10889950147242Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147259Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147266Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147273Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147280Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147297Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147303Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147310Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147327Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147334Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147341Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147358Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147365Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147686Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147785Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147839Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147853Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147860Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147877Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148447Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148454Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
00813677024978PDT, Inc.PDT, INC.EKG2024-06-27
07898506843541QuinelatoSchobell Industrial LtdaEKG2022-12-08
07898506843657QuinelatoSchobell Industrial LtdaEKG2022-12-08
07899798200029QuinelatoSchobell Industrial LtdaEKG2022-12-08