Solanas

GUDID 00844856007901

ADJUSTABLE DRILL SLEEVE

ALPHATEC SPINE, INC.

Orthopaedic implant-instrument extension adaptor, reusable

• Primary Device ID: 00844856007901
• NIH Device Record Key: 2b538b14-125a-4242-ba1c-50c26b7d7449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solanas
• Version Model Number: 63947
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856007901 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

[00844856007901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2020-06-17

On-Brand Devices [Solanas]

• 00844856007185: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 44mm
• 00844856007178: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 40mm
• 00844856007161: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 36mm
• 00844856007147: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 28mm
• 00844856007130: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 24mm
• 00844856007123: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 20mm
• 00844856007116: POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 16mm
• 00844856007697: 3.0mm ROD TEMPLATE, 15cm
• 00190376276274: SOLANAS REV 3 IMPLANTS AND INSTRUMENTS
• 00844856007543: CERVICAL HOOK HOLDER
• 00844856007536: CERVICAL HOOK TRIAL
• 00844856000049: SMALL DEPTH GAUGE 2.7/4.0
• 00844856007581: THORACIC SCREW BONE AWL
• 00844856026933: THORACIC TAP, 4.35mm
• 00844856026926: THORACIC TAP, 3.0mm
• 00844856007512: THORACIC TAP, 4.0mm
• 00844856007505: THORACIC TAP, 3.5mm
• 00844856007901: ADJUSTABLE DRILL SLEEVE
• 00844856051973: SET SCREW INSERTER-HL-R
• 00844856051959: THORACIC SCREW HEAD POSITIONER
• 00844856043459: HEX SET SCREW REMOVAL TOOL
• 00844856026971: CERVICAL HOOK IMPACTER
• 00840967191256: SELF RETAINING SET SCREW INSERTER