FDA.reportPublic FDA data

KLOCKNER

Primary DI
08435451636164
Brand
KLOCKNER
Company
SOADCO, S.L.
Model
KIT MEDGUIDE
Catalog number
KIT MEDGUIDE
Device description
SURGICAL BOX KIT MEDGUIDE
Published
2025-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K243128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243128000Klockner KitsSOADCO, S.L.2024-12-18KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435451636164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435451636164084354516361648435451636164

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+376800593calidad@soadco.com

Regulatory Flags#

DUNS number
464517122
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435451648037KLOCKNER20 51 0120 51 012025-02-18
08435451648044KLOCKNER20 51 0220 51 022025-02-18
08435451648051KLOCKNER20 51 0320 51 032025-02-18
08435451648068KLOCKNER20 51 0420 51 042025-02-18
08435451648075KLOCKNER20 51 0520 51 052025-02-18
08435451648082KLOCKNER20 51 0620 51 062025-02-18
08435451648099KLOCKNER20 51 0720 51 072025-02-18
08435451648105KLOCKNER20 51 0820 51 082025-02-18
08435451648112KLOCKNER20 51 0920 51 092025-02-18
08435451648129KLOCKNER20 51 1020 51 102025-02-18
08435451648136KLOCKNER20 51 1120 51 112025-02-18
08435451648143KLOCKNER20 51 1220 51 122025-02-18
08435451648150KLOCKNER20 51 1320 51 132025-02-18
08435451648167KLOCKNER20 51 1420 51 142025-02-18
08435451648174KLOCKNER20 51 1520 51 152025-02-18
08435451648181KLOCKNER20 51 1620 51 162025-02-18
08435451648198KLOCKNER20 51 1720 51 172025-02-18
08435451648204KLOCKNER20 51 1820 51 182025-02-18
08435451648211KLOCKNER20 51 1920 51 192025-02-18
08435451648228KLOCKNER20 51 2020 51 202025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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