FDA.report

INKA

Primary DI
09348811114853
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
31661.13
Catalog number
31661.13
Device description
BELLUCCI Micro Scissors ø 1.3mm blades 4.5mm long left curved shaft length 80mm
Published
2025-11-26
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
JZBScissors, Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JZBScissors, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09348811114853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09348811114853093488111148539348811114853

GMDN Terms

TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

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
09348811023667INKA15423.112026-03-16
09348811103338INKA30420.142026-03-16
09348811111906INKA31252.032026-03-16
09348811112002INKA31255.082026-03-16
09348811150134INKA31270.16 RD2026-03-16
09348811151254INKA18261.142026-03-16
09348811103321INKA30420.082026-03-09
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09348811114808INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-03
09348811114839INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-01
09348811114976INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-01
09348811114815INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114822INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114860INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115003INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115041INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811172129INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115027INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
09348811172136INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
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