FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H8347210TC0
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
72-10TC
Catalog number
72-10TC
Device description
Wynman Crown Gripper 6-1/4", Tungsten Carbide, without Ratchet
Published
2018-01-31
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
EISREMOVER, CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780438212PrimaryGS10
H8347210TC0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178043821210381780438212

GMDN Terms#

Term, Definition table
TermDefinition
Dental collar/crown scissorsA hand-held dental instrument designed to cut metal bands. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has short, robust, blades that can cut through the thin metal strips (bands). 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
G149TBSB4270TBS BASICSACME ENTERPRISE.EIS2026-05-20
00348783010114Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010121Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010138Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010145Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010152Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010169Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010176Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
G14934001F08TBS DentalACME ENTERPRISE.EIS2026-03-02
04963931210794NAYDM CORPORATIONEIS2025-12-05
04963931210800NAYDM CORPORATIONEIS2025-12-05
00841336106086Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108646Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108660Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
08800075627346OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
08800075627353OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
00841336100916Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125551Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125568Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125599Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
06974456210815CICADAFoshan Cicada Dental Instrument Co., Ltd.EIS2024-08-10
00813677025098PDT, Inc.PDT, INC.EIS2024-07-03
00813677023292PDT, Inc.PDT, INC.EIS2024-07-02
00813677024565PDT, Inc.PDT, INC.EIS2024-07-02
00813677023285PDT, Inc.PDT, INC.EIS2024-07-01
00813677023544PDT, Inc.PDT, INC.EIS2024-07-01
00813677023551PDT, Inc.PDT, INC.EIS2024-07-01
D105SKU1311760SurgiMac Surgimac LLCEIS2024-05-10