FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780414056
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
76D-0
Catalog number
76D-0
Device description
Integra® Miltex® Dental Dam clamp, Style 0
Published
2018-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EEFCLAMP, RUBBER DAM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780414056PrimaryGS10
H83476D00SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178041405610381780414056

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clampA dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. 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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879RDC000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC14A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC201B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC202B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC206B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC207B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2080DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2090DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC210B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC211B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC240DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC24B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22