FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780497011
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
471-87615
Catalog number
471-87615
Device description
EvenWet™ Finishing Strips, #54, Wide, 150 Pack
Published
2018-10-24
Public version status
Update
Distribution status
Not 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
EHMSTRIP, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780497011PrimaryGS10
H834471876151SecondaryHIBCC0
00381780497014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178049701110381780497011
00381780497014003817804970143817804970140381780497014

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
150
Premarket exempt
true
Lot or batch
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
ESUN3048Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46708Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46718Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46728Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46738Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46748Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46768Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46778Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46808Jiffy proximal sawDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46838Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3541008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354LD8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3568Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF356L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3638Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3648Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3668Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF37258Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3738Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF373D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3748Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3768Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF376D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNG30450MM8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30