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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462908035evonosevonos GmbH & Co. KGNNR2026-08-21
04054462908042evonosevonos GmbH & Co. KGNNR2026-08-21
04054462908066evonosevonos GmbH & Co. KGNNR2026-08-21
04054462996810evonosevonos GmbH & Co. KGNNR2026-08-21
00810207784487Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDNNR2026-06-30
00190776421793MillenniumAvalign Technologies, Inc.NNR2026-06-24
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