FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780502852
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
9D-115
Catalog number
9D-115
Device description
"Integra® Miltex® Matrix Scissors, 4-1/2"", Right Angled, One Serrated Blade"
Published
2020-10-01
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
EIRSCISSORS, COLLAR AND CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIRScissors, Collar And CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780502852PrimaryGS10
H8349D1150SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050285210381780502852

GMDN Terms#

Term, Definition table
TermDefinition
Dental collar/crown scissorsA hand-held dental instrument designed to cut metal bands. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has short, robust, blades that can cut through the thin metal strips (bands). 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

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G149TBSB71160TBS BASICSACME ENTERPRISE.EIR2026-05-22
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D105SKU1626031SurgiMac Surgimac LLCEIR2024-04-22
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G586G2535230Novo SurgicalNOVO SURGICAL, INC.EIR2023-12-18
00841336101920Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIR2023-08-10
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00810059291690Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00810059291706Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00810059291713Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
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D127242135A1Artman Instruments Wise Linkers, LLCEIR2023-03-29
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EZPF46674100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
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EZPF46685120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
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