FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780416234
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
V973-62
Catalog number
V973-62
Device description
"Integra® Miltex® No. 7 Wax Spatula, 6-3/4"", Package of 12"
Published
2018-01-22
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
EIKCARVER, WAX, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780416234PrimaryGS10
H834V973621SecondaryHIBCC0
00381780416237Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178041623410381780416234
00381780416237003817804162373817804162370381780416237

GMDN Terms#

Term, Definition table
TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
12
Premarket exempt
true
Lot or batch
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
G149TBSB8080TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8090TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8100TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8110TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8120TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8140TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8150TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8050TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8060TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8070TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8160TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8170TBS BASICSACME ENTERPRISE.EIK2026-05-17
00348783010077Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010084Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010091Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010107Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010060Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-27
00348783012309Premier CarversPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-01
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024937Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
00840018666016Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-09
00840018663671Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665293Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665439Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665446Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018663305Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-29
00840018661172Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
08800075627551OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03