FDA.reportPublic FDA data

Sayan

Primary DI
08698940971454
Brand
Sayan
Company
SAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI
Model
1100.51.038
Catalog number
1100.51.038
Device description
MJOLNIR HAMMER 500 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
08698940971454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08698940971454086989409714548698940971454

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
08698940967426Sayan1100.12.0381100.12.0382026-06-03
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

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Primary DI, Brand, Company table
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00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
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08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03