LACTOSORB SYSTEM 915-2041

GUDID 00841036067991

BIOMET MICROFIXATION, INC

Fluted surgical drill bit, reusable

• Primary Device ID: 00841036067991
• NIH Device Record Key: 50a558ef-d227-4e11-a296-bf1c964663a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LACTOSORB SYSTEM
• Version Model Number: 915-2041
• Catalog Number: 915-2041
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, 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: 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036067991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062842

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[00841036067991]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-10-11

On-Brand Devices [LACTOSORB SYSTEM]

• 00841036159436: SP-1690
• 00841036159429: SP-1689
• 00841036159412: SP-1688
• 00841036056124: 915-3138
• 00841036056117: 915-3137
• 00841036195328: 915-2822
• 00841036195243: SP-2531
• 00841036195236: SP-1966
• 00841036195229: SP-1931
• 00841036151058: SP-2823
• 00841036140298: 72-2013
• 00841036140229: 72-2012
• 00841036140212: 72-2011
• 00841036140182: 72-2014
• 00841036128661: 915-3020
• 00841036125554: SP-1956
• 00841036124250: 915-1565
• 00841036123260: SP-1957
• 00841036084356: 915-3007
• 00841036082239: SP-1377
• 00841036077105: SP-1360
• 00841036077099: SP-1359
• 00841036073787: 915-3205
• 00841036069902: 915-1005
• 00841036067991: 915-2041
• 00841036067465: 915-3204
• 00841036055998: 915-2834
• 00841036055974: 915-2832
• 00841036055899: 915-2812
• 00841036055875: 915-2810
• 00841036055868: 915-2809
• 00841036055851: 915-2808
• 00841036055387: 915-2346
• 00841036055370: 915-2345
• 00841036055363: 915-2344
• 00841036055332: 915-2336
• 00841036055318: 915-2333
• 00841036053864: 915-0020
• 00841036284848: 915-1565
• 00888233025430: SP-2531
• 00888233025423: SP-1966
• 00888233025416: SP-1957
• 00888233025409: SP-1956
• 00888233025393: SP-1931
• 00888233025287: 915-2822