S-ROM 900598210

GUDID 10603295219712

S-ROM A STEM IMPACTOR/INSERTER

DEPUY INTERNATIONAL LTD

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10603295219712
• NIH Device Record Key: d39873f5-ec22-4a65-a85b-a3c20890ee69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-ROM
• Version Model Number: 9005-98-210
• Catalog Number: 900598210
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295219712 [Primary]

FDA Product Code

• HWA: IMPACTOR

Sterilization

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

[10603295219712]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-09-24

On-Brand Devices [S-ROM]

• 10603295219712: S-ROM A STEM IMPACTOR/INSERTER
• 10603295218869: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +9
• 10603295218852: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +3
• 10603295218845: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +9
• 10603295218838: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +3
• 10603295170846: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +12
• 10603295170839: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +6
• 10603295170822: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +0
• 10603295170815: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +12
• 10603295170808: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +6
• 10603295170792: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +0
• 10603295170778: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 22.225mm +0
• 10603295033141: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 28mm +0 12/14 TAPER ULTAMET