FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H83439120
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3-912
Catalog number
3-912
Device description
Iodine Cup, 6 oz., 3-1/4" x 2"
Published
2018-09-12
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
KYWCONTAINER, LIQUID MEDICATION, GRADUATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780468196PrimaryGS10
H83439120SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178046819610381780468196

GMDN Terms#

Term, Definition table
TermDefinition
Medicine cup, reusableA cup specially designed for administering medicine to patients or disabled persons. It will typically be made of stainless steel or durable plastic materials and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. 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
10381780541585CODMAN® ACCU-FLO®82620282-62022024-05-29
10381780541738CODMAN®82304882-30482024-05-29
10381780536918CODMAN® ACCU-FLO®82152082-15202024-05-29
10381780536925CODMAN® ACCU-FLO®82152182-15212024-05-29
10381780537373CODMAN®82409582-40952024-05-29
10381780537380CODMAN®82859182-85912024-05-29
10381780541578CODMAN® ACCU-FLO®82620182-62012024-05-29
10381780541745CODMAN®82304982-30492024-05-29
10381780090977Integra®961020096102002018-10-26
10381780075073Integra®165002516500252018-09-17
10381780075080Integra®165003016500302018-09-17
10381780075097Integra®165005016500502018-09-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000366COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-26
06954454001301COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-26
06954454001318COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-26
06954454001325COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-26
06954454001349COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-26
06954454001356COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-26
06954454000618COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454014837COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015162COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015179COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015186COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454015193COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-24
06954454000656COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000663COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000670COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000687COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000694COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000700COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000717COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454000724COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454001288COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454001295COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
06954454015889COTISENHuanghua Promisee Dental Co., Ltd.KYW2026-10-23
00724995252823V. MuellerSteris CorporationKYW2026-08-21
00724995252830V. MuellerSteris CorporationKYW2026-08-21
00724995252847V. MuellerSteris CorporationKYW2026-08-21
00724995252892V. MuellerSteris CorporationKYW2026-08-21
00724995252908V. MuellerSteris CorporationKYW2026-08-21
00724995252915V. MuellerSteris CorporationKYW2026-08-21
00724995252922V. MuellerSteris CorporationKYW2026-08-21