FDA.reportPublic FDA data

Sayan

Primary DI
08698940967426
Brand
Sayan
Company
SAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI
Model
1100.12.038
Catalog number
1100.12.038
Device description
MJOLNIR HAMMER 250 GR
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08698940967426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08698940967426086989409674268698940967426

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+902324722778serdaromurgoren@sayan.com.tr

Regulatory Flags#

DUNS number
566214005
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
true
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
08698940971454Sayan1100.51.0381100.51.0382026-06-03
08698940973632Sayan1071.58.0011071.58.0012025-10-24
08698940936095Sayan1040.57.0031040.57.0032024-12-24
08698940936101Sayan1040.67.0031040.67.0032024-12-24
08698940936118Sayan1040.77.0031040.77.0032024-12-24
08698940936125Sayan1040.87.0031040.87.0032024-12-24
08698940936132Sayan1040.97.0031040.97.0032024-12-24
08698940936149Sayan1041.07.0031041.07.0032024-12-24
08698940936156Sayan 1041.17.0031041.17.0032024-12-24
08698940936163Sayan1041.27.0031041.27.0032024-12-24
08698940936170Sayan1041.37.0031041.37.0032024-12-24
08698940936187Sayan1041.47.0031041.47.0032024-12-24
08698940936194Sayan1041.57.0031041.57.0032024-12-24
08698940936200Sayan1041.67.0031041.67.0032024-12-24
08698940936217Sayan1041.77.0031041.77.0032024-12-24
08698940936224Sayan1041.87.0031041.87.0032024-12-24
08698940936231Sayan1041.97.0031041.97.0032024-12-24
08698940936248Sayan1042.07.0031042.07.0032024-12-24
08698940936255Sayan1042.17.0031042.17.0032024-12-24
08698940936262Sayan1042.27.0031042.27.0032024-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
07630345728883Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542726170Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753787Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753794Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788833Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788840Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788857Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788864Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788871Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542797699Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542799044Surgical Manual InstrumentMedacta International SALXH2026-05-29