CROWNJUN Nylon Suture NDO528S5

GUDID 14946585285452

KONO SEISAKUSHO CO.,LTD.

Nylon suture, non-bioabsorbable, monofilament
Primary Device ID14946585285452
NIH Device Record Key97543fb2-b5b0-46a4-96ea-bc934d006204
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROWNJUN Nylon Suture
Version Model NumberNDO528S5
Catalog NumberNDO528S5
Company DUNS691486468
Company NameKONO SEISAKUSHO CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104946585285455 [Primary]
GS114946585285452 [Package]
Contains: 04946585285455
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

On-Brand Devices [CROWNJUN Nylon Suture]

14946585249225NDL00W-7
14946585228077NDM00X-7
14946585295581NDH01Y
14946585233972NDZ00Y
04946585336409Contains: NDL00W-7 (Quantity: 4; Primary DI Number: 04946585249228), NDM00X-7 (Quantity: 4; Prim
14946585261135NDH00Y
14946585260664NDU00V-8
14946585285452NDO528S5
04946585284069NDOKA8
14946585275019NDD013B
14946585275002NDD024B
14946585025119NBB024B
14946585025102NBB013B
14946585349680NNWG02V-5-N
04946585349676NNWG03V-5-N
04946585348464NSWG00V-5-N
14946585346436NNWG00V-5-N
14946585357494CROWNJUN Nylon Suture is a sterile, monofilament, synthetic, non-bioabsorbable suture made of ny
04946585350139CROWNJUN Nylon Suture is a sterile, monofilament, synthetic, non-bioabsorbable suture made of ny

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