FDA.reportPublic FDA data

INKA

Primary DI
09348811115003
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
31657.13 BL
Catalog number
31657.13 BL
Device description
SHEA-BELLUCCI Micro Scissors black ø 1.7mm blades 8mm long straight 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

Product Codes#

Code, Name table
CodeName
JZBScissors, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZBScissors, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811115003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811115003093488111150039348811115003

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
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 DI, Brand, Company table
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
09348811114853INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114860INKAThe 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
04250381854136Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250381854143Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250381854150Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676731920Reference instrumentSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745682ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745705ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745736ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-24
04250381854105Shea-Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676708915Scissors model BonnSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676744913Stapes scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676744920Stapes scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746207Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746214Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746221Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746238Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746245Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746269Shea-Bellucci scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746276Shea-Bellucci scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746283House-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08