Primary Device ID | B1132N1HE150480 |
NIH Device Record Key | 22857e4e-836c-40a0-8fa4-4b4991be9b81 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shoulder Innovations Humeral Short Stem |
Version Model Number | 15mm x 48mm |
Catalog Number | 2N1HE15048 |
Company DUNS | 080404519 |
Company Name | SHOULDER INNOVATIONS, LLC |
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 |
Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
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Phone | 616-294-1026 |
xxx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B1132N1HE150480 [Primary] |
MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-01-17 |
Device Publish Date | 2018-12-17 |
B1132N1AB00003 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-07-08 Instrument Case Base, original Shoulder Innovations case base modified to hold InSet Plus glenoid trials |
B1130S1GG00020 - Shoulder Innovations TSA System | 2021-05-12 |
B1130S1GR20065 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
B1130S1GR22065 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
B1130S1SI20006 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
B1130S1SI20008 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
B1132N1AC20005 - Shoulder Innovations TSA | 2021-05-12 Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 5°, Stainless Steel |
B1132N1AC20010 - Shoulder Innovations TSA | 2021-05-12 Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 10°, Stainless Steel |