FDA.report

Signex

Primary DI
08800071031802
Brand
Signex
Company
OSTEONIC CO.,Ltd.
Model
Y7F.35020
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

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800071031802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800071031802088000710318028800071031802

GMDN Terms

TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods

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 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

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