ENDURE INDUSTRIES EA46163U-45

GUDID 00840118611145

Endure Sutures PGLA Undyed, 16mm, 3/8 PRC, 45cm, 4-0

ENDURE INDUSTRIES

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 00840118611145
• NIH Device Record Key: 17dcd1a8-c86b-456a-96de-7d8c28b0fad2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDURE INDUSTRIES
• Version Model Number: EA46163U-45
• Catalog Number: EA46163U-45
• Company DUNS: 066087031
• Company Name: ENDURE INDUSTRIES
• 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: true
• 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

Customer Support Contacts

• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840118611138 [Primary]
GS1	00840118611145 [Package]; Contains: 00840118611138; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130735

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-23
• Device Publish Date: 2023-10-15

On-Brand Devices [ENDURE INDUSTRIES]

• 00840118616737: Expandable Breathing Circuits Pediatric 60"
• 00840118616379: Expandable Breathing Circuits Pediatric 71"
• 00840118616355: Expandable Breathing Circuits Adult 108"
• 00840118615860: Breathing Bags Matte Finish 0.5L
• 00840118613484: Expandable Breathing Circuit Adult 60"
• 00840118606905: Silicone Resuscitator, Disposable
• 00840118611923: PVC Resuscitator, Disposable, Pediatric
• 00840118610049: Anesthesia Breathing Bag 1L Matte Finish
• 00840118610025: Anesthesia Breathing Bag 2L Matte Finish
• 00840118610001: Expandable Breathing Circuit Adult 71"
• 00840118609982: Anesthesia Mask Size 6
• 00840118609968: Anesthesia Mask Size 3
• 00840118609364: Anesthesia Breathing Bag 3L Matte Finish
• 00840118609340: Anesthesia Mask Size 1
• 00840118609326: Anesthesia Mask Size 2
• 00840118609302: Anesthesia Mask Size 4
• 00840118609265: Expandable Breathing Circuit Adult 94"
• 00840118607971: Silicone Laryngeal Mask Airway, Size 5
• 00840118607957: Silicone Laryngeal Mask Airway, Size 4
• 00840118607933: Silicone Laryngeal Mask Airway, Size 3
• 00840118607919: Silicone Laryngeal Mask Airway, Size 2
• 00840118607896: Silicone Laryngeal Mask Airway, Size 1
• 00840118607322: Berman Airway, #5 - 110 mm
• 00840118607315: Berman Airway, #4 - 100 mm
• 00840118607285: Berman Airway, #3 - 90 mm
• 00840118607261: Berman Airway, #2 - 80 mm
• 00840118607247: Berman Airway, #1 - 70 mm
• 00840118607193: Berman Airway, #000 - 40 mm
• 00840118606912: PVC Resuscitator, Disposable, Adult
• 00840118609821: CPR Mask - Adult
• 00840118609944: Anesthesia Mask Size 5
• 00840118615112: Endure Sutures PDO Undyed, 19mm, 3/8 PRC, 75cm, 4-0
• 00840118615099: Endure Sutures NYLON Blue, 60mm, Straight Cutting, 75cm, 2-0
• 00840118615075: Endure Sutures PDO Undyed, 26mm, 1/2 Taper Point, 75cm, 2-0
• 00840118615051: Endure Sutures PDO Undyed, 19mm, 3/8 PRC, 75cm, 3-0
• 00840118615037: Endure Sutures PDO Undyed, 16mm, 3/8 PRC, 75cm, 4-0
• 00840118615013: Endure Sutures PGLA Undyed, 30mm, 3/8 PRC, 75cm, 2-0
• 00840118614993: Endure Sutures PGLA Undyed, 26mm, 3/8 PRC, 75cm, 2-0
• 00840118614979: Endure Sutures PGLA Undyed, 26mm, 3/8 PRC, 75cm, 3-0
• 00840118614955: Endure Sutures PGLA Undyed, 16mm, 3/8 PRC, 75cm, 4-0
• 00840118614542: Endure PDO Violet, 16mm, 3/8 PRC, 45cm, 4-0
• 00840118613651: Endure Skin Closures, Nude Tone, 1/2" x 4"
• 00840118613637: Endure Sutures RPGA Violet, 26mm, 3/8 PRC, 75cm, 3-0
• 00840118613491: Endure Sutures PGA Undyed, 26mm, 3/8 PC, 45cm, 3-0
• 00840118613545: Endure Sutures PGLA Undyed, 16mm, 3/8 PRC, 45cm, 5-0
• 00840118613460: Endure Sutures PDO Violet, 13mm, 3/8 PRC, 45cm, 5-0
• 00840118613446: Endure Sutures PDO Violet, 16mm, 3/8 PRC, 75cm, 4-0
• 00840118613408: Endure Sutures Polypropylene Blue, 40mm, 1/2 TP, 100cm, 1-0
• 00840118613385: Endure Sutures Polypropylene Blue, 19mm, 3/8 PRC, 45cm, 3-0
• 00840118613361: Endure Sutures Polypropylene Blue, 19mm, 3/8 PRC, 75cm, 4-0