FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834THW20
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
THW2
Catalog number
THW2
Device description
Chisel, 2mm, Wedelstaedt, 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
EMLCHISEL, BONE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780399025PrimaryGS10
H834THW20SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178039902510381780399025

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. 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
00348783012316Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEML2026-04-02
00840018672505Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672666Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672970Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018674189Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018667396Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-10
00840018665682Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018666030Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018663732Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665491Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665507Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018661202Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661226Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00194613013448MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013479MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013486MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
D92820001580BAUER GUARDED OSTEO 8MM STRW.H. Holden, Inc.EML2025-05-21
00194613013462MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613104290MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613108601MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00888912126991DJO SURGICALEncore Medical, L.P.EML2024-08-22
00888912127028DJO SURGICALEncore Medical, L.P.EML2024-08-22
00887482050606Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.EML2024-08-12
00813677023254PDT, Inc.PDT, INC.EML2024-07-01
00813677023261PDT, Inc.PDT, INC.EML2024-07-01
00888912088725DJO SURGICALDJO, LLCEML2024-05-20
00842517105652Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06