CROWNJUN Nylon Suture

GUDID 04946585350139

CROWNJUN Nylon Suture is a sterile, monofilament, synthetic, non-bioabsorbable suture made of nylon. CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues. See device description included in 510(k) application.

KONO SEISAKUSHO CO.,LTD.

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 04946585350139
• NIH Device Record Key: f8fa08f7-0b72-4f32-9745-3b5c2afc80bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROWNJUN Nylon Suture
• Version Model Number: NDUG00W
• Company DUNS: 691486468
• Company Name: KONO SEISAKUSHO CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04946585350139 [Primary]
GS1	14946585350136 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192420

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [CROWNJUN Nylon Suture]

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