Quill

GUDID 10848782000002

RB-1 4-0 U Mnd 10x10

Surgical Specialties México, S. de R.L. de C.V.

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 10848782000002
• NIH Device Record Key: 74d7d390-e0be-4f4a-a2b4-e73715c4f0e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quill
• Version Model Number: RS-1010Q
• Company DUNS: 812762226
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782000005 [Primary]
GS1	10848782000002 [Package]; Contains: 00848782000005; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072028

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

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: 2019-06-24
• Device Publish Date: 2019-06-16

On-Brand Devices [Quill]

• 10848782030603: Monoderm 2-0 Violet 20cm UR-6 Uni-directional
• 10848782030597: Monoderm 2-0 Violet 15cm UR-6 Uni-directional
• 10848782029898: CT-3 2-0 U Mnd 16x16 13mm Ldr
• 10848782000002: RB-1 4-0 U Mnd 10x10
• 10848782040190: Polypropylene,Blue,1,15cm,Taper Point,CT-2,Uni-Directional
• 10848782040183: Polypropylene,Blue,1,23cm,Taper Point,CT-2,Uni-Directional
• 10848782040176: Polypropylene,Blue,1,45cm,Taper Point,CT-2,Uni-Directional
• 10848782040169: Polypropylene,Blue,2,70cm,Taper Point,CT-1,Uni-Directional
• 10848782040152: PDO,Violet,0,23cm,Taper Point,CT-2,Uni-Directional
• 10848782040145: PDO,Violet,1,70cm,Reverse Cutting,CP-1,Uni-Directional
• 10848782040138: PDO,Violet,0,70cm,Taper Point,CT-1,Uni-Directional
• 10848782040121: PDO,Violet,1,45cm,Reverse Cutting,CP-1,Uni-Directional
• 10848782040114: PDO,Violet,0,60cm,Reverse Cutting,CP-1,Uni-Directional
• 10848782040107: PDO,Violet,0,70cm,Reverse Cutting,OS-6,Uni-Directional
• 10848782040091: PDO,Violet,0,70cm,Taper Point,CT-2,Uni-Directional
• 10848782040084: PDO,Violet,2-0,70cm,Taper Point,CT-2,Uni-directional
• 10848782040077: PDO,Violet,0,45cm,Reverse Cutting,CP-1,Uni-directional
• 10848782040060: Monoderm,Undyed,0,70cm,Reverse Cutting,PSL,Uni-Directional
• 10848782037145: Polypropylene,Blue,1,15cm,Taper Point,CT-1,Uni-Directional
• 10848782024671: Quill PPN Taper Point 36mm 1/2 Circle Clear 45cm 1, Uni-Directional
• 10848782004772: Quill MONODERM™, 0, 20cm, , 1/2 Circle, Taper Point, 36mm , Uni-directional