FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834MH11160
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
MH11-16
Catalog number
MH11-16
Device description
Cross Action Retractor, 4-1/8", Blunt Prongs
Published
2018-08-22
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
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780488897PrimaryGS10
H834MH11160SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178048889710381780488897

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch

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
B382SD77550140Surgical DirectSurgical Direct, Inc.FFO2026-07-14
B382SD918174150Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD9183701030Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD484610Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484630Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484640Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484650Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484660Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484670Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484680Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484690Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484700Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484710Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484720Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD9147091620Surgical DirectSurgical Direct, Inc.FFO2026-07-09
09348811114068INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811114075INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
B382SD915097010Surgical DirectSurgical Direct, Inc.FFO2026-02-09
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07898506813698QuinelatoSchobell Industrial LtdaFFO2022-12-16
B382SD907632000Surgical DirectSurgical Direct, Inc.FFO2022-12-02
B382SD9228621010Surgical DirectSurgical Direct, Inc.FFO2022-12-01
00192896094710INGE LAMINA SPREADER RETRACTORSONTEC INSTRUMENTS, INC.FFO2019-03-07
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03