Shoulder Innovations InSet FxR 135 Combination Reamer 2L2HR13508

GUDID B1132L2HR135080

Shoulder Innovations - InSet FxR 135 Combination Reamer - 8mmX135

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDB1132L2HR135080
NIH Device Record Keyab8ee562-ded5-406a-bae0-46716a09fa8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations InSet FxR 135 Combination Reamer
Version Model Number8mm Combination Reamer
Catalog Number2L2HR13508
Company DUNS080404519
Company NameShoulder Innovations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1132L2HR135080 [Primary]

FDA Product Code

KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

[B1132L2HR135080]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-22
Device Publish Date2025-12-12

On-Brand Devices [Shoulder Innovations InSet FxR 135 Combination Reamer]

B1132L2HR135140Shoulder Innovations - InSet FxR 135 Combination Reamer - 14mmX135
B1132L2HR135120Shoulder Innovations - InSet FxR 135 Combination Reamer - 12mmX135
B1132L2HR135100Shoulder Innovations - InSet FxR 135 Combination Reamer - 10mmX135
B1132L2HR135080Shoulder Innovations - InSet FxR 135 Combination Reamer - 8mmX135
B1132L2HR135060Shoulder Innovations - InSet FxR 135 Combination Reamer - 6mmX135
B1132L2HR135040Shoulder Innovations - InSet FxR 135 Combination Reamer - 4mmX135
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