FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780499695
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
27-822
Catalog number
27-822
Device description
"Integra® Miltex® Key Periosteal Elevator, 7-1/2"", 1/2"" Wide Blade"
Published
2018-09-18
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
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
HTEELEVATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780499695PrimaryGS10
H834278220SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178049969510381780499695

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267995Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268008Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268015Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268022Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268039Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268046Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
B356KD905230American MedicalsAmerican MedicalsHTE2026-09-25
B356KD910090American MedicalsAmerican MedicalsHTE2026-09-25
00190776431600MillenniumAvalign Technologies, Inc.GEG2026-09-22
00824846008477Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2026-09-19
00190776424091MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776428297MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776427733MillenniumAvalign Technologies, Inc.GEG2026-08-26
00190776427245MillenniumAvalign Technologies, Inc.GEG2026-08-21
00190776424350MillenniumAvalign Technologies, Inc.HTE2026-08-07
00190776422646MillenniumAvalign Technologies, Inc.GEG2026-08-03
00190776422851MillenniumAvalign Technologies, Inc.GEG2026-08-03
B382SD350110Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD38060Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD4833125SN0Surgical DirectSurgical Direct, Inc.GEG2026-08-03
00190776422448MillenniumAvalign Technologies, Inc.GEG2026-07-31
00810143904598SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904604SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904611SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904628SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904642SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906264SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906325SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906370SURGIPROSSurgipros, LLCGEG2026-07-30
00810143907254SURGIPROSSurgipros, LLCGEG2026-07-30