ACUMED

GUDID 10806378013683

3.5mm x 22.0mm Cortical Screw

Acumed LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 10806378013683
• NIH Device Record Key: df184898-e736-4e2f-b8d2-6ac07099b6f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUMED
• Version Model Number: 20-0187
• Company DUNS: 196884852
• Company Name: Acumed LLC
• 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(888)627-9957
• Email: businessservices@acumed.net
• Phone: +1(888)627-9957
• Email: businessservices@acumed.net
• Phone: +1(888)627-9957
• Email: businessservices@acumed.net
• Phone: +1(888)627-9957
• Email: businessservices@acumed.net
• Phone: +1(888)627-9957
• Email: businessservices@acumed.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	10806378013683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942340

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[10806378013683]

Moist Heat or Steam Sterilization

[10806378013683]

Moist Heat or Steam Sterilization

[10806378013683]

Moist Heat or Steam Sterilization

[10806378013683]

Moist Heat or Steam Sterilization

[10806378013683]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-22
• Device Publish Date: 2015-10-24

On-Brand Devices [ACUMED]

• 20806378098991: .094 x 9 STT Wire, 10 pack, WS-2409STT
• 20806378098984: .045 x 6 DT Wire, 10 pack, WS-1106DT
• 20806378098977: .028 x 4 ST Wire, 10 pack, WS-0704ST
• 20806378098960: .045 x 4 ST Wire, 10 pack, WN-1104ST
• 20806378098953: .062x5.75 STT Wire, 10 pack, WT-1606STT
• 20806378098946: .035x5.75 STT Wire, 10 pack, WT-0906STT
• 20806378098939: .094 x 8 STT Wire, 10 pack, WS-2408STT
• 20806378098922: .094 x 8 ST Wire, 10 pack, WS-2408ST
• 20806378098915: .079 x 9 ST Wire, 10 pack, WS-2009ST
• 20806378098908: .062 x 9 STT Wire, 10 pack, WS-1609STT
• 20806378098885: .062 x 6 ST Wire, 10 pack, WS-1607ST
• 20806378098878: .062 x 6 DT Wire, 10 pack, WS-1606DT
• 20806378098854: .054 x 7 ST Wire, 10 pack, WS-1407ST
• 20806378098847: .054 x 6 ST Wire, 10 pack, WS-1406ST
• 20806378098830: .045 x 6 ST Wire, 10 pack, WS-1106ST
• 20806378098823: .035 x 5.75 ST Wire, 10 pack, WS-0906ST
• 20806378098816: .028 x 6 ST Wire, 10 pack, WS-0706ST
• 20806378098809: .035 x 6 DT Wire, 10 pack, 80-1525
• 20806378098793: .035 x 6 ST Wire, 10 pack, 80-1524
• 20806378098786: .094 x 9.25 STT Wire, 10 pack, 80-0971
• 20806378098779: .094 x 9.25 ST Wire, 10 pack, 80-0970
• 20806378098762: .062 x 9.25 ST Wire, 10 pack, 80-0950
• 20806378098755: .062 x 8 ST Wire, 10 pack, 80-0413
• 20806378098748: .035 x 6 ST Wire, 10 pack, 80100101
• 20806378045995: 5 Pk Acu-Loc® 2 T-Guide Retainer, Small
• 20806378029520: .035 X 6 DT Wire, 10-Pack - 80-1525-S
• 20806378029513: .035 X 6 ST Wire, 10-Pack - 80-1524-S
• 20806378029506: .062 X 5.75 STT Wire 10pk - WT-1606STT-S
• 20806378029490: .035 X 5.75 STT Wire 10pk - WT-0906STT-S
• 20806378029476: .094 x 9 ST Wire, 10-pack - WS-2409ST-S
• 20806378029469: .094 x 8 STT Wire, 10-pack -WS-2408STT-S
• 20806378029452: .094 x 8 ST Wire, 10-pack - WS-2408ST-S
• 20806378029445: .062 x 9 STT Wire, 10-pack -WS-1609STT-S
• 20806378029438: .062 x 9 ST Wire, 10-pack - WS-1609ST-S
• 20806378029421: .062 X 6 ST Wire, 10-pack - WS-1607ST-S
• 20806378029414: .062 X 6 DT Wire, 10-pack - WS-1606DT-S
• 20806378029407: .028 x 6 ST Wire, 10-PACK - WS-0706ST-S
• 20806378029391: .028 X 4 ST Wire 10-PACK - WS-0704ST-S
• 20806378029384: .054 x 7 ST Wire, 10-pack - WS-1407ST-S
• 20806378029377: .054 x 6 Wire, 10-pack - WS-1406ST-S
• 20806378029360: .045 x 6 ST Wire, 10-pack - WS-1106ST-S
• 20806378029353: .045 X 6 DT Wire 10-PACK - WS-1106DT-S
• 20806378029346: .035 x 5.75 ST Wire 10-pack -WS-0906ST-S
• 20806378029339: .045 x 4 ST Wire 10-PACK - WN-1104ST-S
• 20806378029322: ATM-078-S, Mini Acutrak® Drill, 5-pack
• 20806378029315: ATM-099-S, Mini Acutrak® Drill Long, 5pk
• 20806378029308: ATF-037-S 37mm Acutrak® Fusion Drill 5pk
• 20806378029292: ATF-032-S 32mm Acutrak® Fusion Drill 5pk
• 20806378029285: ATF-024-S 24mm Acutrak® Fusion Drill 5pk
• 20806378029278: AT-7044-S, Std. Acutrak® Dense Drill 5pk