FDA.reportPublic FDA data

Integra®

Primary DI
10381780083146
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3724064
Catalog number
3724064
Device description
Integra® House Cutting Block, Autoclavable
Published
2018-10-24
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
NNRBLOCK, CUTTING, ENT, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNRBlock, Cutting, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780083146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008314610381780083146

GMDN Terms#

Term, Definition table
TermDefinition
Dissection boardA flat, stiff device on which an object (a human or animal body or body part) is placed for support during dissection 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
Manufacturing date on label
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
04250676741882Cutting blockSpiggle & Theis Medizintechnik GmbHNNR2025-09-25
00190776407810MillenniumAvalign Technologies, Inc.NNR2025-08-01
00194613022167MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00194613030223MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00887482040379Symmetry TeflonASPEN SURGICAL PRODUCTS, INC.NNR2024-09-09
G043670000BEARBear-Ent, LLCNNR2024-08-15
00840183503512BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840183527396BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840306827525Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827532Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827549Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827556Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00190776293307MILLENNIUMAvalign Technologies, Inc.NNR2023-09-28
00190776320874MILLENNIUMAvalign Technologies, Inc.NNR2023-09-28
00840319753132Hayden MedicalHayden Medical, Inc.NNR2023-05-26
00842962145807HNM MEDICALHNM STAINLESS, LLC.NNR2023-04-03
14026704805690PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
54026704805698PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
14026704805683PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
00840306806865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00840306806889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00842331134210Novo Surgical Inc. NOVO SURGICAL, INC.NNR2022-11-10
00840306806872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-08
04250374712269Cutting block, glassSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250381850169Preparation tray, stainless steelSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250676732354Fisch cutting and preparation jigSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250676732361Fisch cutting and preparation jigSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250676735393Piston cutting jigSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
00840319705803Hayden MedicalHayden Medical, Inc.NNR2022-07-27
00190776045289AvalignAvalign Technologies, Inc.NNR2021-11-03