FDA.reportPublic FDA data

NA

Primary DI
07612334227980
Brand
NA
Company
Synthes GmbH
Model
68.190.000
Catalog number
68190000
Device description
TRAY FOR OPERACE, 1 FROM 2
Published
2025-07-23
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
K241927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241927000Synthes Graphic Case & Tray SystemSynthes GmbH2025-03-28KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612334227980Direct MarkingGS10
10886982338839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334227980076123342279807612334227980
1088698233883910886982338839

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. 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
486711679
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
10886982262257TRAUMACEM07.702.040S07702040S2017-10-06
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095372INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095389INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095396INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095402INSTRUSAFESummit Medical, Inc.KCT2026-10-29
07899995223999ORGANIZER BOX VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237705Organizer Box Intraoral Pro Scanning PremiumSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237712Beyond Full Arch Surgical KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237729Intraoral Pro Scanning Premium KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237736Intraoral Pro Scanning Starter KitSin Sistema de Implante Nacional S/AKCT2026-10-29
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006680Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006697Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006703Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006710Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006734Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006758Mastel SurgicalMastel Surgical Inc.KCT2026-10-23