Pisces-SA 1750-L098

GUDID B0621750L098

29x39x09, 8°, Trial, PISCES-SA

Osseus Fusion Systems, LLC

Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter
Primary Device IDB0621750L098
NIH Device Record Key1e9eea31-5f12-4128-8da8-db0f1aa636a8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePisces-SA
Version Model Number1750-L098
Catalog Number1750-L098
Company DUNS933442068
Company NameOsseus Fusion Systems, LLC
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0621750L098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


[B0621750L098]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-26
Device Publish Date2022-05-18

On-Brand Devices [Pisces-SA]

B0621790000720° Trial Module, PISCES™-SA
B0621790000616° Trial Module, PISCES™-SA
B0621790000512° Trial Module, PISCES™-SA
B0621752L17029x39x17, 20°, Trial, PISCES-SA
B0621750S19823x29x19, 8°, Trial, PISCES-SA
B0621750S19623x29x19, 16°, Trial, PISCES-SA
B0621750S19223x29x19, 12°, Trial, PISCES-SA
B0621750S19023x29x19, 20°, Trial, PISCES-SA
B0621750S17823x29x17, 8°, Trial, PISCES-SA
B0621750S17623x29x17, 16°, Trial, PISCES-SA
B0621750S17223x29x17, 12°, Trial, PISCES-SA
B0621750S17023x29x17, 20°, Trial, PISCES-SA
B0621750S15823x29x15, 8°, Trial, PISCES-SA
B0621750S15623x29x15, 16°, Trial, PISCES-SA
B0621750S15223x29x15, 12°, Trial, PISCES-SA
B0621750S15023x29x15, 20°, Trial, PISCES-SA
B0621750S13823x29x13, 8°, Trial, PISCES-SA
B0621750S13623x29x13, 16°, Trial, PISCES-SA
B0621750S13223x29x13, 12°, Trial, PISCES-SA
B0621750S13023x29x13, 20°, Trial, PISCES-SA
B0621750S11823x29x11, 8°, Trial, PISCES-SA
B0621750S11623x29x11, 16°, Trial, PISCES-SA
B0621750S11223x29x11, 12°, Trial, PISCES-SA
B0621750S11023x29x11, 20°, Trial, PISCES-SA
B0621750S09823x29x09, 8°, Trial, PISCES-SA
B0621750S09623x29x09, 16°, Trial, PISCES-SA
B0621750S09223x29x09, 12°, Trial, PISCES-SA
B0621750S07823x29x07, 8°, Trial, PISCES-SA
B0621750S07623x29x07, 16°, Trial, PISCES-SA
B0621750S07223x29x07, 12°, Trial, PISCES-SA
B0621750M19826x35x19, 8°, Trial, PISCES-SA
B0621750M19626x35x19, 16°, Trial, PISCES-SA
B0621750M19226x35x19, 12°, Trial, PISCES-SA
B0621750M19026x35x19, 20°, Trial, PISCES-SA
B0621750M17826x35x17, 8°, Trial, PISCES-SA
B0621750M17626x35x17, 16°, Trial, PISCES-SA
B0621750M17226x35x17, 12°, Trial, PISCES-SA
B0621750M17026x35x17, 20°, Trial, PISCES-SA
B0621750M15826x35x15, 8°, Trial, PISCES-SA
B0621750M15626x35x15, 16°, Trial, PISCES-SA
B0621750M15226x35x15, 12°, Trial, PISCES-SA
B0621750M15026x35x15, 20°, Trial, PISCES-SA
B0621750M13826x35x13, 8°, Trial, PISCES-SA
B0621750M13626x35x13, 16°, Trial, PISCES-SA
B0621750M13226x35x13, 12°, Trial, PISCES-SA
B0621750M13026x35x13, 20°, Trial, PISCES-SA
B0621750M11826x35x11, 8°, Trial, PISCES-SA
B0621750M11626x35x11, 16°, Trial, PISCES-SA
B0621750M11226x35x11, 12°, Trial, PISCES-SA
B0621750M11026x35x11, 20°, Trial, PISCES-SA

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