FDA.report

Surgical Instrument

Primary DI
08809539697390
Brand
Surgical Instrument
Company
OSTEONIC CO.,Ltd.
Model
Y1G.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
HTJGauge, Depth

Product Code Classifications

CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809539697390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809539697390088095396973908809539697390

GMDN Terms

TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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

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08800071022534SignexS3H.503202025-07-01
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08800071022589SignexS3H.504202025-07-01
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08800071022602SignexS3H.504602025-07-01

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