CUSTOM A36020510

GUDID 03613720284048

T25 LOCKING CAP INSERTER

MEDICREA INTERNATIONAL

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03613720284048
• NIH Device Record Key: 6125c589-a22e-41c6-8d60-d42ebd8a5b36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSTOM
• Version Model Number: A36020510
• Catalog Number: A36020510
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03613720284048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190376

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

[03613720284048]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

On-Brand Devices [CUSTOM]

• 03613720276074: DISTRACTOR Ø6 mm
• 03613720276067: DISTRACTOR Ø5 mm
• 03613720275800: DUAL NUT INSERTER
• 03613720274438: BL TIP FOR PASS LP SCREWDRIVER
• 03613720274421: BL TIP FOR PASS TULIP SCREWDRIVER
• 03613720270997: PASS TULIP SCREWDRIVER TIP FOR STEALTH NAVIGATION
• 03613720270966: PASS LP SCREWDRIVER TIP FOR STEALTH NAVIGATION
• 03613720270751: PASS TULIP POWER ATTACHMENT
• 03613720247715: PEDICLE SCREWDRIVER WITH 4-SLOT QUICK CONNECT
• 03613720223689: SPRINGLESS PEDICLE SCREWDRIVER
• 03613720223665: SHORT POST PEDICLE SCREWDRIVER SHAFT FOR 1/4 POWERED DRILL"
• 03613720223634: NUTDRIVER
• 03613720223344: STANDARD CONNECTOR HOLDER
• 03613720223313: NUTDRIVER
• 03613720223306: PEDICLE SCREWDRIVER SHAFT FOR 1/4 POWERED DRILL DEVICE
• 03613720223290: AO NUTHOLDER AND NUTDRIVER SHAFT
• 03613720223245: CANNULATED PEDICLE SCREWDRIVER FOR 1/4 POWERED DRILL DEVICE
• 03613720223092: AO NUTDRIVER SHAFT
• 03613720223061: SHORT PEDICLE SCREWDRIVER SHAFT
• 03613720222743: SCREWDRIVER SHAFT
• 03613720222422: PUT-OUT PLIERS FOR HOLDER
• 03613720222408: KUCH MINI ACCESS ROD HOLDER
• 03613720222361: NUTDRIVER SHAFT FOR 1/4 POWERED DRILL DEVICE
• 03613720222354: PEDICLE SCREWDRIVER SHAFT FOR 1/4 POWERED DRILL DEVICE
• 03613720222262: MALLEABLE ROD L: 450mm
• 03613720222231: SCREDWDRIVER SHAFT FOR PASS LP HOOK HEAD
• 03613720222224: LONG NUTDRIVER FOR PASS LP
• 03613720222217: CAGE IMPIX-C 8 AND 9mm HOLDER WITH END STOP 8mm - 9mm
• 03613720222200: CAGE IMPIC C HOLDER WITH END STOP
• 03613720222194: PEDICLE SCREWDRIVER SHAFT FOR PASS V2
• 03613720222187: PEDICLE SCREWDRIVER SHAFT FOR PASS V1
• 03613720223528: CURETTE
• 03613720282525: DUAL ENDED PEDICLE FEELER
• 03613720282983: SCREW REMOVER
• 03613720275770: IB3D TB trial 15mm at 6°
• 03613720275763: IB3D TB trial 14mm at 6°
• 03613720275756: IB3D TB trial 13mm at 6°
• 03613720275749: IB3D TB trial 12mm at 6°
• 03613720275732: IB3D TB trial 11mm at 6°
• 03613720275718: IB3D TB trial 9mm at 6°
• 03613720275701: IB3D TB trial 8mm at 6°
• 03613720282723: OFFSET HEAD POSITIONER
• 03613720282693: Screw remover for Stabolt
• 03613720283614: Hook holder
• 03613720284048: T25 LOCKING CAP INSERTER
• 03613720283997: STRAIGHT SPATULA
• 03613720283256: PASS TULIP 40mm TAP Ø6.5mm
• 03613720283072: TULIP GENESIS POWER M LOCKING SCREWDRIVER
• 03613720283065: PASS Tulip POWER M Tap with Sleeve Ø10.5mm
• 03613720283058: PASS Tulip POWER M Tap with Sleeve Ø9.5mm