FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780510734
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
DP5400
Catalog number
DP5400
Device description
DenLite® LED Charger Set Only
Published
2018-10-23
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
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780510734PrimaryGS10
H834DP54001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178051073410381780510734

GMDN Terms#

Term, Definition table
TermDefinition
Portable/mobile rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). 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
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02
10381780519089CODMAN® HAKIM®82309782-30972020-06-02
10381780519195CODMAN® HAKIM®82311682-31162020-06-02
10381780519249CODMAN® HAKIM®82316482-31642020-06-02
10381780519256CODMAN® HAKIM®82318282-31822020-06-02
10381780519263CODMAN® HAKIM®82318482-31842020-06-02
10381780519447CODMAN® HAKIM®82328182-32812020-06-02
10381780519478CODMAN® HAKIM®82328482-32842020-06-02
10381780519485CODMAN® HAKIM®82328582-32852020-06-02
10381780519751CODMAN® HAKIM®82382182-38212020-06-02
10381780519768CODMAN® HAKIM®82382282-38222020-06-02
10381780519799CODMAN® HAKIM®82382582-38252020-06-02
10381780519805CODMAN® HAKIM®82383282-38322020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456225424JMUJMU DENTAL, INCEAX2026-10-14
00840456225431JMUJMU DENTAL, INCEAX2026-10-14
00840161312174Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840161312181Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840161312198Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
D955MM5CSFS1Paul BandittTerlain Enterprises, Inc.EAX2026-09-25
G879MMFS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
00840456218341JMUJMU DENTAL, INCEAX2026-07-07
00840456218358JMUJMU DENTAL, INCEAX2026-07-07
00840456218365JMUJMU DENTAL, INCEAX2026-07-07
00840456218372JMUJMU DENTAL, INCEAX2026-07-07
00840456218389JMUJMU DENTAL, INCEAX2026-07-07
00840456218396JMUJMU DENTAL, INCEAX2026-07-07
08961104622579Dental Mouth Mirror MELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622586Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622944Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
G149TBSB3110TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3120TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3130TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3140TBS BASICSACME ENTERPRISE.EAX2026-05-16
1081000052669420/20™PARKELL, INC.EAX2025-09-26
M633680501B4JEDMEDJEDMED INSTRUMENT COMPANYEAX2023-02-03
10371347002550Mirror Front Surface Cone Socket #4The Atlanta Dental Supply CompanyEAX2022-11-23