Swede Dental SIEXC64-65Z

GUDID 00841013117565

EXCAVATOR 64-65 (3/8) SS

AMERICAN EAGLE INSTRUMENTS, INC.

Dental excavator, reusable

• Primary Device ID: 00841013117565
• NIH Device Record Key: 7da87265-383e-41a9-991d-3eaa00bd4207
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swede Dental
• Version Model Number: SIEXC64-65Z
• Catalog Number: SIEXC64-65Z
• Company DUNS: 790776850
• Company Name: AMERICAN EAGLE INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com
• Phone: +1 (800) 551 5172
• Email: customerservice@am-eagle.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841013117565 [Primary]

FDA Product Code

• EKC: EXCAVATOR, DENTAL, OPERATIVE

Sterilization

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

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

[00841013117565]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-31
• Device Publish Date: 2022-10-23

On-Brand Devices [Swede Dental]

• 00841013117923: SCALER M23 THIN-THIN (3/8) BLACK
• 00841013117909: SCALER 204SD (3/8) YELLOW
• 00841013117886: PROBE 12 BLACK (3/8)
• 00841013117862: SWEDE DENTAL MHR SIMPLE STEM (3/8)
• 00841013117664: GRACEY ACCESS 13-14 THIN-THIN (3/8) BLUE/BLUE
• 00841013117657: GRACEY ACCESS 1-2 (3/8) PURPLE
• 00841013117640: GRACEY ACCESS 11-12 THIN-THIN (3/8)OR/OR
• 00841013117626: GRACEY 13-14 THIN-THIN 3/8 BLUE
• 00841013117619: GRACEY 11-12 THIN-THIN (3/8) ORANGE
• 00841013117602: EXPLORER DE 5 (3/8)
• 00841013117596: EXCAVATOR 74-75 (3/8) SS
• 00841013117589: EXCAVATOR 70-71 (3/8) SS
• 00841013117572: EXCAVATOR 651-61 (3/8) SS
• 00841013117565: EXCAVATOR 64-65 (3/8) SS
• 00841013117541: EXCAVATOR 611-21 (3/8) SS
• 00841013117534: EXPL/PROBE 23/12 (Black)(3/8)
• 00841013117527: EXPL/PROBE 23/2-12 BLACK (3/8)