FDA.reportPublic FDA data

INTERSEAL®

Primary DI
M6844820SH00001
Brand
INTERSEAL®
Company
Microport Orthopedics Inc.
Model
4820SH0000
Catalog number
4820SH0000
Published
2016-12-30
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
HYAFORCEPS, WIRE HOLDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6844820SH00001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
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
00192629087255ProfemurPHAC1202PHAC12022026-05-14
00192629087262ProfemurPHAC1204PHAC12042026-05-14
00192629087279ProfemurPHAC1212PHAC12122026-05-14
00192629087286ProfemurPHAC1214PHAC12142026-05-14
00192629087293ProfemurPHAC1222PHAC12222026-05-14
00192629087309ProfemurPHAC1224PHAC12242026-05-14
00192629087316ProfemurPHAC1232PHAC12322026-05-14
00192629087323ProfemurPHAC1234PHAC12342026-05-14
00192629087330ProfemurPHAC1242PHAC12422026-05-14
00192629087347ProfemurPHAC1244PHAC12442026-05-14
00192629087354ProfemurPHAC1252PHAC12522026-05-14
00192629324077ProphecyPNV08601PNV086012021-05-20
00192629324084ProphecyPNV08602PNV086022021-05-20
00192629324091ProphecyPNV08603PNV086032021-05-20
00192629324107ProphecyPNV08604PNV086042021-05-20
00192629324114ProphecyPNV08605PNV086052021-05-20
00192629324121ProphecyPNV08606PNV086062021-05-20
00192629324138ProphecyPNV08607PNV086072021-05-20
00192629324145ProphecyPNV08608PNV086082021-05-20
00192629324152ProphecyPNV08609PNV086092021-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04250603753100LAZICPeter Lazic GmbHHYA2026-03-25
00194613028886MSI Precision Specialty InstrumentsMed Saver, Inc.HYA2025-08-01
03760225714096In2BonesIN2BONESHYA2024-12-13
04250603748526LAZICPeter Lazic GmbHHYA2024-11-20
04250603749295LAZICPeter Lazic GmbHHYA2024-11-20
03700569626877Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
03700569626884Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
04049197473248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
04049197473255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
00840183516758BR Surgical, LLCBR Surgical, LLCHYA2024-06-03
00840180519301General InstrumentsALPHATEC SPINE, INC.HYA2023-09-22
07898506853717QuinelatoSchobell Industrial LtdaHYA2023-07-07
07898506848676QuinelatoSchobell Industrial LtdaHYA2023-07-05
07898506814312QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853601QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853618QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853625QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853649QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853724QuinelatoSchobell Industrial LtdaHYA2022-12-16
07899798203310SchobellSchobell Industrial LtdaHYA2022-11-28
00840180508336General InstrumentsALPHATEC SPINE, INC.HYA2022-10-13
00887482055410Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HYA2022-08-25
00850027837642StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
00850027837659StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
04250603736608LAZICPeter Lazic GmbHHYA2021-12-22
04250603739487LAZICPeter Lazic GmbHHYA2021-12-22
00850027837529StabilICEACUTUS MEDICAL, INC.HYA2021-10-28
04250603736103LAZICPeter Lazic GmbHHYA2021-07-02
04250603736110LAZICPeter Lazic GmbHHYA2021-07-02