UNICRYL M SD10036

GUDID 06285379148841

Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / Ligatures.

UNITED MEDICAL INDUSTRIES CO. LTD

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 06285379148841
• NIH Device Record Key: 90c369de-39a4-4904-bb27-3e20d318fb98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNICRYL M
• Version Model Number: SD10036
• Catalog Number: SD10036
• Company DUNS: 535040901
• Company Name: UNITED MEDICAL INDUSTRIES CO. LTD
• Device Count: 12
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa
• Phone: +966112650665
• Email: qa@unimed.com.sa

Device Dimensions

• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter
• Outer Diameter: 0.2 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06285379148841 [Unit of Use]
GS1	16285379148848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042285

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

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: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by UNITED MEDICAL INDUSTRIES CO. LTD

• 06285379148810 - UNICRYL: 2020-05-08 Braided Coated Polyglycolic Acid (PGA) Synthetic Absorbable Surgical Sutures / Ligatures.
• 06285379148827 - UNICRYL quick: 2020-05-08 Braided Coated Polyglycolic Acid (PGA) (Fast Absorbing) Synthetic Absorbable Surgical Sututres / Ligatures
• 06285379148834 - UNIGLACTIN: 2020-05-08 Braided Coated Polyglactin Synthetic Absorbable Surgical Sututres / Ligatures
• 06285379148841 - UNICRYL M: 2020-05-08Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / Ligatures.
• 06285379148841 - UNICRYL M: 2020-05-08 Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / Ligatures.
• 06285379148858 - UNICAPRONE: 2020-05-08 Monofilament Polyglecaprone 25 Synthetic Absorbable Surgical Sututres / Ligatures
• 06285379148865 - UNIPRO: 2020-05-08 Monofilament Polypropylene Synthetic non-absorbable Surgical Sututres / Ligatures
• 06285379148872 - UNISILK: 2020-05-08 Braided Silk, Natural Non-Absorbable Surgical Sututres / Ligatures
• 06285379148889 - UNISILK V: 2020-05-08 Virgin Silk, Natural Non-Absorbable Surgical Sututres / Ligatures