FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780416548
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
V97-622
Catalog number
V97-622
Device description
"Integra® Miltex® Bozeman Dressing Forceps, 10-3/4"", Double Curved"
Published
2017-10-30
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
HDMPACKER, UTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDMPacker, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780416548PrimaryGS10
H834V976220SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178041654810381780416548

GMDN Terms#

Term, Definition table
TermDefinition
Uterine packerA hand-held, surgical instrument used to introduce dressings into the uterus or vagina. 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
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
00612479143579McKessonMCKESSON MEDICAL-SURGICAL INC.HDM2020-05-04
00304040022993Henry ScheinHENRY SCHEIN, INC.HDM2019-05-16
00612479141933McKessonMCKESSON MEDICAL-SURGICAL INC.HDM2018-11-19
10885403043437V. MuellerSTERIS CORPORATIONHDM2018-08-30
10885403043444V. MuellerSTERIS CORPORATIONHDM2018-08-30
10381780487043Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487050Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487067Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487074Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308400Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308450Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308500Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308550Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10885403042126V. MuellerSTERIS CORPORATIONHDM2018-08-17
10381780409458Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409465Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409472Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409489Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409496Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780479468Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419461Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419511Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419561Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419661Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
H834308350Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780438441Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
10381780440734Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
H834MH76220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
H834V976220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2017-10-30