Henry Schein 900-7488

GUDID 20304040000636

HS DSM19 4-0 UN PGA-PCL 18"/45

HENRY SCHEIN, INC.

Poliglecaprone suture

• Primary Device ID: 20304040000636
• NIH Device Record Key: f0b99157-dc46-4626-9d47-6a2e8bc8355d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein
• Version Model Number: 900-7488
• Catalog Number: 900-7488
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040000632 [Primary]
GS1	20304040000636 [Package]; Contains: 00304040000632; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052437

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-25

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• 10304040057107: Skin Staple Remover with Gauze Sponge
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• 10304040054304: CU1000 Halogen Curing Light
• 10304040054267: Essentials LED Curing Light, Silver
• 10304040054250: Essentials LED Curing Light, Black
• 10304040054243: Essentials LED Curing Light
• 10304040053222: Stadiometer
• 00304040053218: Digital Remote Indicator Scale 500 lb capacity
• 00304040053201: Digital Hand Rail Scale with Height Rod, 1000lb capacity
• 00304040053171: Digital Wheelchair Scale 1,000 lb capacity
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• 10304040039707: Suture Chromic Gut C-3
• 10304040039691: Suture Polysyn PGA Violet C-6
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• 10304040039608: Suture PGA PCL Mono DSM13
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• 10304040039578: Suture PGA PCL Mono DSM13
• 10304040039561: Suture PGL PCL Mono DSM19
• 10304040039554: Suture PGA PCL Mono DSM19
• 10304040039523: Suture Chromic Gut Bge T
• 00304040039519: CENTRIFUGE MIRCROHEMATOCR
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• 10304040039479: Bur Block Plastic 8 Hole
• 10304040039462: Bur Block Plastic 14 Hole
• 10304040039455: Bur Block Plastic 8 Hole
• 10304040039448: Bur Block Plastic 8 Hole
• 10304040039431: Bur Block Plastic 14 Hole
• 10304040039424: Bur Block Plastic 14 Hole
• 10304040039417: Bur Block Magnetic 8 Hole
• 10304040039400: Bur Block Magnetic 14 Hole
• 10304040039394: Bur Block Magnetic 8 Hole
• 10304040039387: Bur Block Magnetic 14 Hole
• 10304040039370: Bur Block Magnetic 8 Hole
• 10304040039363: Bur Block Magnetic 14 Hole
• 00304040037089: Calcium Hydroxide Temporary Root Filling Material
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• 10304040026547: Sharps Container, 8 Gallon Red
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• 10304040026523: Sharps Container 1 Gallon Red
• 10304040026516: Sharps Container 2Gal Red
• 10304040026509: Sharps Collector Phlebotomy
• 00304040023976: Zirlux Temp PMMA 100x20mm
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