FDA.report

INKA

Primary DI
09348811038784
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
18603.30
Catalog number
18603.30
Device description
Ruler mm/inch graduated 30cm
Published
2025-12-02
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

Related Records

Product Codes

CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications

CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09348811038784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09348811038784093488110387849348811038784

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
742109993
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
09348811023018INKA15341.152026-03-16
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09348811103338INKA30420.142026-03-16
09348811111906INKA31252.032026-03-16
09348811112002INKA31255.082026-03-16
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09348811151254INKA18261.142026-03-16
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09348811150288INKA31241.16 RD2026-03-09
09348811150356INKA31252.12 RD2026-03-09
09348811000873INKA10236.3010236.302026-02-13
09348811000897INKA10237.1510237.152026-02-13
09348811000903INKA10237.1710237.172026-02-13
09348811000927INKA10237.1410237.142026-02-13
09348811000934INKA10237.2010237.202026-02-13
09348811000941INKA10237.2310237.232026-02-13
09348811000958INKA10237.2810237.282026-02-13
09348811000965INKA10237.3010237.302026-02-13
09348811000972INKA10237.3310237.332026-02-13
09348811000989INKA10237.3610237.362026-02-13

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