Emerald Cervical PEEK C-P-032

GUDID B104CP0320

7mm Emerald Parallel Cervical PEEK

GLASIR MEDICAL LP

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDB104CP0320
NIH Device Record Key9b3f24cd-09e6-4836-8fa5-3b75e68db351
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmerald Cervical PEEK
Version Model NumberC-P-032
Catalog NumberC-P-032
Company DUNS066151033
Company NameGLASIR MEDICAL LP
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 Usetrue
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB104CP0320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B104CP0320]

Moist Heat or Steam Sterilization


[B104CP0320]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-04-05

On-Brand Devices [Emerald Cervical PEEK]

B104CP037012mm Emerald Parallel Cervical PEEK
B104CP036011mm Emerald Parallel Cervical PEEK
B104CP035010mm Emerald Parallel Cervical PEEK
B104CP03409mm Emerald Parallel Cervical PEEK
B104CP03308mm Emerald Parallel Cervical PEEK
B104CP03207mm Emerald Parallel Cervical PEEK
B104CP03106mm Emerald Parallel Cervical PEEK
B104CP03005mm Emerald Parallel Cervical PEEK
B104CL037012mm Emerald Lordotic Cervical PEEK
B104CL036011mm Emerald Lordotic Cervical PEEK
B104CL035010mm Emerald Lordotic Cervical PEEK
B104CL03409mm Emerald Lordotic Cervical PEEK
B104CL03308mm Emerald Lordotic Cervical PEEK
B104CL03207mm Emerald Lordotic Cervical PEEK
B104CL03106mm Emerald Lordotic Cervical PEEK

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