FDA.reportPublic FDA data

Sayan

Primary DI
08698940936170
Brand
Sayan
Company
SAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI
Model
1041.37.003
Catalog number
1041.37.003
Device description
Acetabular Reamer Hex Coupling Ø50
Published
2024-12-24
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
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
08698940936170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08698940936170086989409361708698940936170

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
Premarket exempt
true
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
08698940967426Sayan1100.12.0381100.12.0382026-06-03
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
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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00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
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