FDA.reportPublic FDA data

Integra®

Primary DI
10381780074526
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
1352277
Catalog number
1352277
Device description
Integra® QuickLock Speculum Mount
Published
2018-09-17
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
FXGSPECULA ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXGSpecula AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780074526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007452610381780074526

GMDN Terms#

Term, Definition table
TermDefinition
ENT speculum holderA device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands-free during a surgical intervention. The holder is typically fastened to the side rail of the operating table and can be adjusted to a desired position. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04030155000644Ear funnel, grey, small, Ø 2,5 mm, PU = 1000 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2026-06-25
04030155000675Ear funnel, grey, large, Ø 4,0 mm, PU = 1000 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2026-06-25
00850071684308REALSTAR SURGICAL INSTRUMENTSREAL STAR SURGICAL INSTRUMENTSFXG2025-09-09
04030155000774Reusable ear funnels Ø 4.0 mm, 10 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2024-07-24
00840183503987BR Surgical, LLCBR Surgical, LLCFXG2024-02-06
00190776317799MillenniumAvalign Technologies, Inc.FXG2023-11-13
04030155000613Ear funnel, black, small Ø 2.5 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000637Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000651Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000668Ear funnel, small, grey, Ø 2.5 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000682Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000699Ear funnel, large, grey, Ø 4.0 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
00190776042479AvalignAvalign Technologies, Inc.FXG2023-06-23
00840183506872BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
00840183510725BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
14026704806307PILLINGTELEFLEX INCORPORATEDFXG2022-12-08
54026704806305PILLINGTELEFLEX INCORPORATEDFXG2022-12-08
00842331151125Novo Surgical Inc. NOVO SURGICAL, INC.FXG2022-11-12
00887482116463Symmetry SheaASPEN SURGICAL PRODUCTS, INC.FXG2022-09-29
27290018446120N9 speculumNONAGON LTDFXG2021-09-13
07290018446126N9 speculumNONAGON LTDFXG2021-09-13
10812594011853Neotech Ocular Exam KitNeotech Products LLCFXG2021-06-14
10812594012485Neonatal Ocular Exam Kit 2-packNeotech Products LLCFXG2021-06-14
10812594012492Neotech Ocular Exam KitNeotech Products LLCFXG2021-06-14
10812594012508Ocular Exam DepressorNeotech Products LLCFXG2021-06-14
10812594012515Ocular Exam Neonatal SpeculumNeotech Products LLCFXG2021-06-14
10812594012522Ocular Exam Standard SpeculumNeotech Products LLCFXG2021-06-14
00812594011856Ocular Exam Kit NeonatalNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012488Neonatal Ocular Exam Kit 2-packNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012495Ocular Exam Kit StandardNEOTECH PRODUCTS, INC.FXG2021-06-14