ZIP

GUDID B52100104045

ZIP All-In-One Compressor 45mm

AURORA SPINE, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device IDB52100104045
NIH Device Record Keye510f2ff-c8bd-4ec1-a9d2-44ad9c44e5eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameZIP
Version Model Number001-040-45
Company DUNS079119091
Company NameAURORA SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCB52100104045 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


[B52100104045]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-11
Device Publish Date2022-02-03

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B521001012MZIP0ZIP ULTRA MIS Interspinous Fusion System, 12mm x 40mm
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B521001010SZIP0ZIP ULTRA MIS Interspinous Fusion System, 10mm x 35mm
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B52100104045ZIP All-In-One Compressor 45mm

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