FDA.reportPublic FDA data

Surgical Instrument

Primary DI
08809539697468
Brand
Surgical Instrument
Company
OSTEONIC CO.,Ltd.
Model
Y1D.35010
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08809539697468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809539697468088095396974688809539697468

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688999370
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
false
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
08800071055440ASTERN3A.201702026-03-19
08800071001539SignexS1B.355202025-07-01
08800071001546SignexS1B.355802025-07-01
08800071001553SignexS1B.356202025-07-01
08800071004295SignexC7.304802025-07-01
08800071004301SignexC7.305002025-07-01
08800071022473SignexS3H.502002025-07-01
08800071022480SignexS3H.502202025-07-01
08800071022497SignexS3H.502402025-07-01
08800071022503SignexS3H.502602025-07-01
08800071022510SignexS3H.502802025-07-01
08800071022527SignexS3H.503002025-07-01
08800071022534SignexS3H.503202025-07-01
08800071022541SignexS3H.503402025-07-01
08800071022558SignexS3H.503602025-07-01
08800071022565SignexS3H.503802025-07-01
08800071022572SignexS3H.504002025-07-01
08800071022589SignexS3H.504202025-07-01
08800071022596SignexS3H.504402025-07-01
08800071022602SignexS3H.504602025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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