FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834TZC10110
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
TZC1011
Catalog number
TZC1011
Device description
Carver, Contour Carbide 10-11, Double-Ended, Tactile Tone™
Published
2018-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10381780465430PrimaryGS10
H834TZC10110SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178046543010381780465430

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam carver, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically for cutting, scraping, paring, and smoothing finishes and fashioning patterns. It will typically be a double-ended instrument made of high-grade stainless steel and have a solid blunt blade/nib of various sizes and designs with 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
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
false
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