FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780419150
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-2150-B
Catalog number
19-2150-B
Device description
"Integra® Miltex® Bellucci Micro Ear Scissors 3"" Shaft, Straight, 4mm Blades, Ebony Finish"
Published
2017-12-21
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
JZBSCISSORS, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZBScissors, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780419150PrimaryGS10
H834192150B0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178041915010381780419150

GMDN Terms#

Term, Definition table
TermDefinition
Ear scissors, reusableA long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length4Millimeter
Width0.9Millimeter

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
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

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Primary DI, Brand, Company table
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04054462908400evonosevonos GmbH & Co. KGJZB2026-08-21
04054462911424evonosevonos GmbH & Co. KGJZB2026-08-19
04054462911431evonosevonos GmbH & Co. KGJZB2026-08-19
04054462911448evonosevonos GmbH & Co. KGJZB2026-08-19
04054462911622evonosevonos GmbH & Co. KGJZB2026-08-19
09348811114846INKAThe Trustee for KAISER FAMILY TRUSTJZB2026-07-31
00190776404208MillenniumAvalign Technologies, Inc.JZB2026-07-24
00190776404215MillenniumAvalign Technologies, Inc.JZB2026-07-24
05060212051042Crocodile Scissors Straight, stainless steelDTR MEDICAL LIMITEDJZB2026-06-10
05060212051059Crocodile Scissors Curved, stainless steelDTR MEDICAL LIMITEDJZB2026-06-10
09348811114891INKAThe Trustee for KAISER FAMILY TRUSTJZB2026-04-24
09348811114808INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-03
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09348811115027INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
09348811172136INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
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04250381854143Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250381854150Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
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