Primary Device ID | B1132L1S1400000 |
NIH Device Record Key | a72fe4b0-53e4-4c25-a0f6-376535d37e7f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shoulder Innovations InSet 70 Humeral Stem |
Version Model Number | 14x70mm |
Catalog Number | 2L1S140000 |
Company DUNS | 080404519 |
Company Name | Shoulder Innovations, Inc. |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com | |
Phone | 616-294-1026 |
info@shoulderinnovations.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B1132L1S1400000 [Primary] |
MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
[B1132L1S1400000]
Radiation Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-06 |
Device Publish Date | 2025-05-29 |
B1132L2HI000040 | Shoulder Innovations - InSet 70 Humeral Stem - Instrument: Impaction Stand Adapter |
B1132L1S1400000 | Shoulder Innovations - InSet 70 Humeral Stem - 14x70mm |
B1132L1S1200000 | Shoulder Innovations - InSet 70 Humeral Stem - 12x70mm |
B1132L1S1000000 | Shoulder Innovations - InSet 70 Humeral Stem - 10x70mm |
B1132L1S0800000 | Shoulder Innovations - InSet 70 Humeral Stem - 8x70mm |
B1132L1S0600000 | Shoulder Innovations - InSet 70 Humeral Stem - 6x70mm |
B1132L1S0400000 | Shoulder Innovations - InSet 70 Humeral Stem - 4x70mm |