FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834308350
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
30-835
Catalog number
30-835
Device description
Cheron Uterine Dressing Forceps, 10-1/2", Rings Angled Sideways, Serrated Jaws 6.8mm x 32mm
Published
2018-08-16
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
HDMPACKER, UTERINE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780479468PrimaryGS10
H834308350SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178047946810381780479468

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length25Millimeter
Width5.4Millimeter

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
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
10381780438441Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
10381780440734Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
H834MH76220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
10381780416548Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2017-10-30
H834V976220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2017-10-30