FDA.reportPublic FDA data

NA

Primary DI
10886705032266
Brand
NA
Company
Medos International Sàrl
Model
242333
Catalog number
242333
Device description
PUREVUE Quick Connect Cannula System Tray
Published
2026-07-22
Public version status
New
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
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253791000PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.2026-02-26KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705032266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670503226610886705032266

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
false
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
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
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
10705034369983SKYLINE4102901304102901302016-12-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095488INSTRUSAFESummit Medical, Inc.KCT2026-11-05
00385640095471INSTRUSAFESummit Medical, Inc.KCT2026-11-04
10886982278746NASynthes GmbHKCT2026-11-03
10886982346421NASynthes GmbHKCT2026-11-03
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00841536147971ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147988ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148015ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148237ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148336ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148343ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148350ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148367ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147445ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147452ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147469ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147476ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147322ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147353ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147414ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148022ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148312ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148480ThompsonThompson Surgical Instruments, Inc.KCT2026-08-12
00841536148459ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536148466ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536147162ThompsonThompson Surgical Instruments, Inc.KCT2025-12-09
00841536146516ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146523ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146875ThompsonThompson Surgical Instruments, Inc.KCT2025-08-28
00841536146912ThompsonThompson Surgical Instruments, Inc.KCT2025-07-08