MONDEAL 27-05601

GUDID 04050435067488

Pilot Drill 2.1 x 110 mm WL 60 mm AO cannulated 1 x yellow 1 x grey for 3.0 mm screws

MONDEAL Medical Systems GmbH

Cannulated surgical drill bit, reusable

• Primary Device ID: 04050435067488
• NIH Device Record Key: b0156b3b-e4de-4e1a-b84d-dc18ec3fb634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONDEAL
• Version Model Number: 27-05601
• Catalog Number: 27-05601
• Company DUNS: 312546955
• Company Name: MONDEAL Medical Systems GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +497463993070
• Email: mail@mondeal.de
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1904-641-7746
• Email: KLS-UDI-Info@klsmartin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04050435067488 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

[04050435067488]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-06-26

On-Brand Devices [MONDEAL]

• 04050435118463: Separation sheet for inlay with empty space
• 04050435118456: Inlay for AKIN and CHEVRON Implants for screws Ø 1.7 / Ø 2.0 / Ø 2.3 mm, 1/4
• 04050435118159: Basket L for instruments 243 x 253 x 76 mm
• 04050435117602: Basket complete incl. 4 silicone instrument racks and lid 273 x 84 x 41
• 04050435117466: Instrument bar from silocone 160 x 34 mm
• 04050435117190: MRP-Plate right M3 green
• 04050435117183: MRP-Plate left M3 green
• 04050435116803: MCD blade not self-retaining M4 AO 1 x red
• 04050435116797: MOW plate with wedge 8 mm M2 gold
• 04050435116780: MOW plate with wedge 7 mm M2 gold
• 04050435116773: MOW plate with wedge 6 mm M2 gold
• 04050435116766: MOW plate with wedge 5 mm M2 gold
• 04050435116759: MOW plate with wedge 4 mm M2 gold
• 04050435116742: MOW plate with wedge 3 mm M2 gold
• 04050435116735: K-Wire 1.5 x 70 mm with olive Ø 6 mm Trocar pointed round shaft M2 / M3
• 04050435116728: K-Wire 1.5 x 70 mm with olive Ø 4 mm Trocar pointed round shaft M1
• 04050435116667: MCD Screw 2.3 x 14 mm cannulated M1 partially threaded thread length 5.6 mm violet
• 04050435116650: MCD Screw 2.3 x 12 mm cannulated M1 partially threaded thread length 4.8 mm violet
• 04050435116643: MCD Screw 2.3 x 10 mm cannulated M1 partially threaded thread length 4 mm violet
• 04050435116636: K-Wire 2.5 x 200 mm Trocar point threaded round shaft
• 04050435116629: MCD blade M4 for 200 mm K-Wire cannulated not self-retaining AO 1 x red
• 04050435116612: MCD blade not self-retaining M3 AO 1 x green
• 04050435116605: MCD blade not self-retaining M2 AO 1 x yellow
• 04050435116599: MCD blade not self-retaining M1 AO 1 x blue
• 04050435116582: K-Wire 1.4 x 150 mm Trocar point threaded round shaft
• 04050435116575: K-Wire 1.4 x 150 mm Trocar pointed round shaft
• 04050435116490: Identification label MBM blue
• 04050435116483: Basket S without lid 269 x 171 x 93 mm
• 04050435116469: Drill guide for Module 3
• 04050435116452: Drill guide for Module 2
• 04050435116445: Drill guide for Module 1
• 04050435116315: Inlay Clip for length 45 mm
• 04050435116308: Inlay Clip for length 35 mm
• 04050435116292: Inlay Clip for length 25 mm
• 04050435116278: MCD Screw 6.5 x 25 mm cannulated M4 partially threaded thread length 12 mm grey
• 04050435116261: MCD Screw 6.5 x 30 mm cannulated M4 partially threaded thread length 15 mm grey
• 04050435116254: MCD Screw 6.5 x 35 mm cannulated M4 partially threaded thread length 17 mm grey
• 04050435116247: MCD Screw 6.5 x 40 mm cannulated M4 partially threaded thread length 20 mm grey
• 04050435116230: MCD Screw 6.5 x 45 mm cannulated M4 partially threaded thread length 22 mm grey
• 04050435115950: 4-hole X-Plate L M2 gold
• 04050435115943: 4-hole X-Plate M M2 gold
• 04050435115936: 4-hole X-Plate S M2 gold
• 04050435115608: Identification label BMR • MPS • FRACTURE SYSTEM blue
• 04050435115592: Identification label BMR • FRACTURE SYSTEM blue
• 04050435115585: Identification label MPS • FRACTURE SYSTEM blue
• 04050435115578: Identification label BMR • MPS SYSTEM blue
• 04050435115561: Identification label FRACTURE SYSTEM blue
• 04050435115554: Identification label BMR SYSTEM blue
• 04050435115547: Identification label MPS SYSTEM blue
• 04050435115530: Identification label MONDE | mandible blue