DCP 449034

GUDID H9804490340

2.0MM TI DCP PLATE 4 HOLES/30MM

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

• Primary Device ID: H9804490340
• NIH Device Record Key: 96d4f0d4-957c-4a00-802b-21b6678e0e62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DCP
• Version Model Number: 449.034
• Catalog Number: 449034
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587054056 [Primary]
HIBCC	H9804490340 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954385

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

[H9804490340]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [DCP]

• H9804490380: 2.0MM TI DCP PLATE 8 HOLES/54MM
• H9804490370: 2.0MM TI DCP PLATE 7 HOLES/48MM
• H9804490360: 2.0MM TI DCP PLATE 6 HOLES/42MM
• H9804490350: 2.0MM TI DCP PLATE 5 HOLES/32MM
• H9804490340: 2.0MM TI DCP PLATE 4 HOLES/30MM
• H9804490320: 2.0MM TI ANGLED DCP PLATE 4 X 4 HOLES/21MM X 21MM
• H980443580: 2.0MM TI MF DCP PLATE 8 HOLES/42MM
• H980443570: 2.0MM TI MF DCP PLATE 7 HOLES/37MM
• 10887587051048: 2.0MM TI MF DCP PLATE 6 HOLES/32MM
• 10887587051031: 2.0MM TI MF DCP PLATE 5 HOLES/27MM
• H980443540: 2.0MM TI MF DCP PLATE 4 HOLES/22MM
• H6794440220: 2.7MM TI DCP® PLATE 2 HOLES/26MM
• H6794440120: 2.7MM TI DCP® PLATE 12 HOLES/100MM
• H6794440100: 2.7MM TI DCP® PLATE 10 HOLES/84MM
• H6794440090: 2.7MM TI DCP® PLATE 9 HOLES/76MM
• H6794440080: 2.7MM TI DCP® PLATE 8 HOLES/68MM
• H6794440070: 2.7MM TI DCP® PLATE 7 HOLES/60MM
• H6794440060: 2.7MM TI DCP® PLATE 6 HOLES/52MM
• H6794440050: 2.7MM TI DCP® PLATE 5 HOLES/44MM
• H6794440040: 2.7MM TI DCP® PLATE 4 HOLES/36MM
• H6794440020: 2.7MM TI DCP® PLATE 2 HOLES/20MM
• H6794430580: 2.0MM TI DCP® PLATE 8 HOLES/42MM
• H6794430570: 2.0MM TI DCP® PLATE 7 HOLES/37MM
• H6794430560: 2.0MM TI DCP® PLATE 6 HOLES/32MM
• H6794430550: 2.0MM TI DCP® PLATE 5 HOLES/27MM
• H6794430540: 2.0MM TI DCP® PLATE 4 HOLES/22MM
• H679243580: 2.0MM DCP® PLATE 8 HOLES/42MM
• H679243570: 2.0MM DCP® PLATE 7 HOLES/37MM
• H679243560: 2.0MM DCP® PLATE 6 HOLES/32MM
• H679243550: 2.0MM DCP® PLATE 5 HOLES/27MM
• H679243540: 2.0MM DCP® PLATE 4 HOLES/22MM
• H679322440: 4.5MM DCP® DRILL GUIDE NEUTRAL & LOAD
• H679322430: 4.5MM DCP® HIP DRILL GUIDE NEUTRAL & LOAD 60MM
• H679322320: 3.5MM DCP® DRILL GUIDE NEUTRAL & LOAD
• H679322210: 2.7MM DCP® DRILL GUIDE NEUTRAL & LOAD
• H679322150: 2.0MM DCP® DRILL GUIDE NEUTRAL & LOAD
• H679244220: 2.7MM DCP® PLATE 2 HOLES/26MM
• H679244120: 2.7MM DCP® PLATE 12 HOLES/100MM
• H679244100: 2.7MM DCP® PLATE 10 HOLES/84MM
• H679244090: 2.7MM DCP® PLATE 9 HOLES/76MM
• H679244080: 2.7MM DCP® PLATE 8 HOLES/68MM
• H679244070: 2.7MM DCP® PLATE 7 HOLES/60MM
• H679244060: 2.7MM DCP® PLATE 6 HOLES/52MM
• H679244050: 2.7MM DCP® PLATE 5 HOLES/44MM
• H679244040: 2.7MM DCP® PLATE 4 HOLES/36MM
• H679244020: 2.7MM DCP® PLATE 2 HOLES/20MM
• H679248220: 3.5MM DCP PLATE 22 HOLES/265MM
• H679248200: 3.5MM DCP PLATE 20 HOLES/242MM
• H679248050: 3.5MM DCP PLATE 5 HOLES/61MM
• H679248030: 3.5MM DCP PLATE 3 HOLES/37MM