EXEL SCALPELS ,S-S, SIZE:15

GUDID 10020221295563

EXEL SCALPELS ,S-S, SIZE:15

Exel International

Scalpel, single-use

• Primary Device ID: 10020221295563
• NIH Device Record Key: a3b18e11-b6cb-4bff-83ab-1631a897fc9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL SCALPELS ,S-S, SIZE:15
• Version Model Number: 29556
• Company DUNS: 180572216
• Company Name: Exel International
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221295566 [Primary]
GS1	10020221295563 [Package]; Contains: 00020221295566; Package: Inner Box [10 Units]; In Commercial Distribution
GS1	20020221295560 [Package]; Package: Outer Box [10 Units]; In Commercial Distribution
GS1	30020221295567 [Package]; Contains: 20020221295560; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895771

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2023-03-17
• Device Publish Date: 2023-03-09

Devices Manufactured by Exel International

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• 00020221063004 - EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER S: 2025-10-07 EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER STOP, DOUBLE BAGGED, 100/BX, 400/CRTN.
• 00020221162011 - 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL;: 2025-10-07 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 2,000PC/DOUBLE PE BAG/CRTN
• 00020221163001 - EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL: 2025-10-07 EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL ; 140/BOX, 560/CRTN
• 00020221464146 - EXEL HYPO NDL 21GX1"; BULK, NON-STERILE, NON-SILICONIZED: 2025-10-07 EXEL HYPO NDL 21GX1"; BULK, NON-STERILE, NON-SILICONIZED; 20,000PCS / CASE (2X10k DOUBLE BAGS)
• 00020221660487 - EXEL 1mL TB SYR ONLY,BULK,N-S: 2025-10-07 EXEL 1mL TB SYR ONLY,BULK,N-S 2000/BAG, 4,000/CS
• 00020221660494 - EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE: 2025-10-07 EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE 2000/BAG, 4000/CS