ACTIVBRAID AB-021R-1B

GUDID 00810063820381

ACTIVBRAID Collagen-UHMWPE Co-Braid 2-0 Suture w/ 3/8c Taper Point Needle, Blue

Embody, Inc.

Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture Collagen-polymer suture

• Primary Device ID: 00810063820381
• NIH Device Record Key: 04550c75-961f-487d-aff7-620119e4af26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIVBRAID
• Version Model Number: AB-021R-1B
• Catalog Number: AB-021R-1B
• Company DUNS: 079544913
• Company Name: Embody, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00810063820381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223822

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [ACTIVBRAID]

• 00810063820442: ACTIVBRAID Collagen-UHMWPE Co-Braid 2.5mm Suture Tape, Blue
• 00810063820435: ACTIVBRAID Collagen-UHMWPE Co-Braid 1.5mm Suture Tape w/ 1/2c Taper Point Needle, Blue
• 00810063820428: ACTIVBRAID Collagen-UHMWPE Co-Braid 1.5mm Suture Tape w/ 1/2c Taper Point Needle, White/Black
• 00810063820411: ACTIVBRAID Collagen-UHMWPE Co-Braid 2 Suture w/ 1/2c Taper Point Needle, Blue
• 00810063820404: ACTIVBRAID Collagen-UHMWPE Co-Braid 2 Suture w/ 1/2 Taper Point Needle, White/Black
• 00810063820398: ACTIVBRAID Collagen-UHMWPE Co-Braid 2.5mm Suture Tape, White/Black
• 00810063820381: ACTIVBRAID Collagen-UHMWPE Co-Braid 2-0 Suture w/ 3/8c Taper Point Needle, Blue