FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780426547
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
27-1600
Catalog number
27-1600
Device description
"Integra® Miltex® Liston Amputating Knife 11-1/2"", 159mm Blade"
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
GDNKNIFE, AMPUTATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDNKnife, AmputationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780426547PrimaryGS10
H8342716000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178042654710381780426547

GMDN Terms#

Term, Definition table
TermDefinition
Amputation knifeA hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length159Millimeter

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

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Primary DI, Brand, Company table
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24026704941654PILLINGTELEFLEX INCORPORATEDGDN2026-02-11
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00840343725563GEN2SURGIX MEDICAL LLCGDN2025-02-11
B356EE173000American MedicalsAmerican MedicalsGDN2024-11-12
04049197022613RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
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B356126CL120American MedicalsAmerican MedicalsGDN2024-05-14
G586N91281280Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
G586N91281310Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
00190776062033AvalignAvalign Technologies, Inc.GDN2023-09-28
00190776289218MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
00190776343408MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
B356BH420280American MedicalsAmerican MedicalsGDN2023-09-28
00810123205929Adler Instrument CompanyAdler, Inc.GDN2023-06-16
00842962107140HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842962160565HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842331143984Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-11
00842331134623Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-10
B35607423200American MedicalsAmerican MedicalsGDN2022-09-21
B35607423240American MedicalsAmerican MedicalsGDN2022-09-21
B356BH420130American MedicalsAmerican MedicalsGDN2022-09-16