FDA.reportPublic FDA data

SKYLINE

Primary DI
10705034369983
Brand
SKYLINE
Company
Medos International Sàrl
Model
410290130
Catalog number
410290130
Device description
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TRADITIONAL TEMPLATE CADDY
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034369983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503436998310705034369983

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04
00856879006281FIBERGRAFT Aeridyan Matrix59000063590000632021-08-04
00856879006298FIBERGRAFT Aeridyan Matrix59000015590000152021-08-04
00856879006304FIBERGRAFT Aeridyan Matrix59000030590000302021-08-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995239992V. MuellerSteris CorporationFSM2026-10-15
00724995240004V. MuellerSteris CorporationFSM2026-10-15
00724995240011V. MuellerSteris CorporationFSM2026-10-15
00724995240028V. MuellerSteris CorporationFSM2026-10-15
00724995243401V. MuellerSteris CorporationFSM2026-10-15
00889795150271APEX 3D Total Ankle Replacement SystemParagon 28, Inc.FSM2026-10-12
00190446960386Active AdaptiveMedshape, Inc.FSM2026-10-09
00850045406615clamp-itGeneral Hospital Supply CorpFSM2026-10-01
00190776434588MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776434595MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776435899MillenniumAvalign Technologies, Inc.FSM2026-09-30
16931918122397AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918176680AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918191614AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
10888857252820DENALI® Spinal SystemVB Spine LLCFSM2026-08-28
10888857253056DENALI® Spinal SystemVB Spine LLCFSM2025-12-18
10888857291980MESA® Spinal SystemVB Spine LLCFSM2025-12-18
10888857446267MESA® Spinal SystemVB Spine LLCFSM2025-12-18
10888857381551YUKON OCT Spinal SystemVB Spine LLCFSM2025-12-09
10888857291850MESA® Spinal SystemVB Spine LLCFSM2025-12-08
10888857446274MESA® Spinal SystemVB Spine LLCFSM2025-12-08