FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780425298
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
25-202
Catalog number
25-202
Device description
"Integra® Miltex® Bailey-Gibbon Rib Contractor 7-3/4"""
Published
2018-01-12
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
FZRCONTRACTOR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZRContractor, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780425298PrimaryGS10
H834252020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178042529810381780425298

GMDN Terms#

Term, Definition table
TermDefinition
Rib spreader, reusableA self-locking surgical instrument designed to force apart two adjacent ribs to permit examination or intervention in the thoracic cavity. This device will typically have two interchangeable blades at the distal end that hook over the ribs to be parted, and a ratchet mechanism along its horizontal bar to adjust the blades and maintain its set position once it has been set. It is also known as a rib retractor and is available in various designs and sizes. It is typically made of high-grade stainless steel but types used for paediatrics may be made of corrosive resistant aluminium (Al). 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
10381780190424Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-31
10381780190431Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-31
10381780190448Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-31
M2743002301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-31
M2743002311Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-31
M2743002351Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-31
10381780425281Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-12
H834252000Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-12
H834252020Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZR2018-01-12