PRIMA 9013.67.435

GUDID 08033390214582

PRIMA - Cemented Axial reamer #6-7

LIMACORPORATE SPA

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 08033390214582
• NIH Device Record Key: 65d212ff-fa09-4575-bd23-6b5c57299e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMA
• Version Model Number: 9013.67.435
• Catalog Number: 9013.67.435
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390214582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212800

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

[08033390214582]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-25
• Device Publish Date: 2022-03-17

On-Brand Devices [PRIMA]

• 08033390217385: PRIMA - Metaphyseal K-Wire
• 08033390217330: PRIMA - Pin Dia.3x100mm
• 08033390215497: PRIMA - Trial Tray #S - Insert #S RET 0° 40 - +0mm
• 08033390215473: PRIMA - Trial Tray #M - Insert #M 7° 40 - +6mm
• 08033390215442: PRIMA - Trial Tray #M - Insert #S 7° 40- +3mm
• 08033390215428: PRIMA - Trial Tray #S - Insert #S 7° 40 - +0mm
• 08033390215329: PRIMA - Trial Tray #M - Insert #M 0° 40 - +6mm
• 08033390215312: PRIMA - Trial Tray #M - Insert #S 0° 40- +3mm
• 08033390215305: PRIMA - Trial Tray #S - Insert #S 0° 40 - +0mm
• 08033390215299: PRIMA - Trial Tray #M - Insert #M RET 7° 36 - +6mm
• 08033390215282: PRIMA - Trial Tray #M - Insert #S RET 7° 36- +3mm
• 08033390215244: PRIMA - Trial Tray #S - Insert #S RET 7° 36 - +0mm
• 08033390215237: PRIMA - Trial Tray #M - Insert #M RET 0° 36 - +6mm
• 08033390215220: PRIMA - Trial Tray #M - Insert #S RET 0° 36- +3mm
• 08033390215213: PRIMA - Trial Tray #S - Insert #S RET 0° 36 - +0mm
• 08033390215206: PRIMA - Trial Tray #M - Insert #M 7° 36 - +6mm
• 08033390215190: PRIMA - Trial Tray #M - Insert #S 7° 36- +3mm
• 08033390215138: PRIMA - Trial Tray #S - Insert #S 7° 36 - +0mm
• 08033390215107: PRIMA - Trial Tray #M - Insert #M 0° 36 - +6mm
• 08033390215091: PRIMA - Trial Tray #M - Insert #S 0° 36 - +3mm
• 08033390215053: PRIMA - Trial Tray #S - Insert #S 0° 36 - +0mm
• 08033390214551: PRIMA - Reverse Insert/Tray Extractor
• 08033390214544: PRIMA - Anatomic Head Extractor
• 08033390214520: PRIMA - Reverse Insert/Tray Assembly Block
• 08033390214513: PRIMA - Anatomical trial adaptor
• 08033390214506: PRIMA - Adaptor for humeral cover
• 08033390213707: PRIMA - Metaphyseal Removal Reamer Stopper
• 08033390213578: PRIMA - Humeral Head Adaptors Extractor
• 08033390213561: PRIMA - Counter-torque handle for anatomical adaptors
• 08033390213493: PRIMA - Humeral IM Rod
• 08033390203715: PRIMA - Reverse Insert # MEDIUM Dia.42mm 7° Corr
• 08033390203708: PRIMA - Reverse Insert # SHORT Dia.42mm 7° Corr.RETENTIVE
• 08033390203692: PRIMA - Reverse Insert # SHORT Dia.42mm 7° Corr
• 08033390203685: PRIMA - Reverse Insert # MEDIUM Dia.42mm 0° Corr.RETENTIVE
• 08033390203661: PRIMA - Reverse Insert # SHORT Dia.42mm 0° Corr.RETENTIVE
• 08033390203395: PRIMA - Reverse Insert # SHORT Dia.40mm 7° Corr.RETENTIVE
• 08033390203388: PRIMA - Reverse Insert # SHORT Dia.40mm 7° Corr.
• 08033390203371: PRIMA - Reverse Insert # MEDIUM Dia.40mm 0° Corr.RETENTIVE
• 08033390203364: PRIMA - Reverse Insert # MEDIUM Dia.40mm 0° Corr.
• 08033390203340: PRIMA - Reverse Insert # SHORT Dia.40mm 0° Corr
• 08033390203333: PRIMA - Trial Stem #7
• 08033390203326: PRIMA - Trial Stem #6
• 08033390203319: PRIMA - Trial Stem #5
• 08033390203302: PRIMA - Trial Stem #4
• 08033390203296: PRIMA - Trial Stem #3
• 08033390203289: PRIMA - Trial Stem #2
• 08033390203272: PRIMA - Trial Stem #1
• 08033390203029: PRIMA - Reverse Insert # MEDIUM Dia.36mm 0° Corr.RETENTIVE
• 08033390203012: PRIMA - Reverse Insert # MEDIUM Dia.36mm 7° Corr.
• 08033390203005: PRIMA - Reverse Insert # SHORT Dia.36mm 7° Corr.RETENTIVE