FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780383215
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
TCHL12GK
Catalog number
TCHL12GK
Device description
Carver, Hollenback 1-2, Black-Green, Tactile Tone™
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
EKHCARVER, DENTAL AMALGAM, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780383215PrimaryGS10
H834TCHL12GK0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178038321510381780383215

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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
G149TBSB4090TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4100TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4110TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4120TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4130TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4280TBS BASICSACME ENTERPRISE.EKH2026-05-20
10889950005375HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005382HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005399HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005405HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005412HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005429HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005436HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005443HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005450HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005467HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005474HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005481HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005498HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005504HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005818HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005825HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006907HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006914HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006921HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006938HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007072HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007423HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007430HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007447HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12