FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780423607
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
21-288
Catalog number
21-288
Device description
"Joseph Nasal Saw 4"", Angled Right, 1-1/2"" x 1/8"" Blade"
Published
2018-01-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBCSAW, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBCSaw, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780423607PrimaryGS10
H834212880SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178042360710381780423607

GMDN Terms#

Term, Definition table
TermDefinition
Nasal sawA hand-held manual surgical instrument designed for cutting bone and/or cartilage in the nose. It is typically a one-piece metal instrument made of high-grade surgical steel with a handle at the proximal end and a long, thin, serrated blade at the distal end with the cutting teeth set in a straight line, a rounded nose at the tip, and a smooth edge on the top side of the blade to protect tissue not intended to be cut. The instrument is typically used in plastic (i.e., rhinoplasty) and reconstructive procedures of the nose. 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
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G586E7871330Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871210Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871220Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871230Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871320Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871330Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
00840319753804Hayden MedicalHayden Medical, Inc.KBC2023-10-20
G4252005020My MedicalMy Medical Store LLCKBC2023-08-27
00192896114708Wellenschliff Nasal SawSONTEC INSTRUMENTS, INC.KBC2023-04-28
00842331174797Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-14
00842331158032Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-12
00842331130250Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-10
00840329807320N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
00840329807337N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
00840329807344N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
B089B621500N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
B089B621510N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
B089B621520N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
00840319722008Hayden MedicalHayden Medical, Inc.KBC2022-08-08
00840319722015Hayden MedicalHayden Medical, Inc.KBC2022-08-08
00840319707043Hayden MedicalHayden Medical, Inc.KBC2022-07-27
00840319707074Hayden MedicalHayden Medical, Inc.KBC2022-07-27
00840319707081Hayden MedicalHayden Medical, Inc.KBC2022-07-27
04046826472221MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
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04046826116187MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24