FDA.reportPublic FDA data

NA

Primary DI
10886982348326
Brand
NA
Company
Synthes GmbH
Model
SD60.133.150
Catalog number
SD60133150
Device description
SCREW RACK 3.0 & 4.0
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10886982348326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698234832610886982348326

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00385640092197INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092203INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092210INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092227INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092234INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092241INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092258INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092265INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092272INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092289INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092296INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092302INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092319INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092326INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092333INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092340INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092357INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092364INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092371INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092388INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092395INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092401INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092418INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092425INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092432INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092449INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092456INSTRUSAFESummit Medical, Inc.KCT2026-08-07