Primary Device ID | 00815362023228 |
NIH Device Record Key | 0ca3813e-460b-4fd3-8dd2-51055fd888be |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INTERBODY CAGES |
Version Model Number | 11085PS |
Catalog Number | 23-PC1855-12 |
Company DUNS | 079398589 |
Company Name | PRECISION SPINE, INC. |
Device Count | 1 |
DM Exempt | true |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815362023228 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815362023228]
Moist Heat or Steam Sterilization
[00815362023228]
Moist Heat or Steam Sterilization
[00815362023228]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2016-11-15 |
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00840019930949 - Reform POCT System | 2024-04-17 Ø3.5 x 36mm Polyaxial Screw - M/L Bias |
00840019930956 - Reform POCT System | 2024-04-17 Ø3.5 x 38mm Polyaxial Screw - M/L Bias |
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00840019930987 - Reform POCT System | 2024-04-17 Ø4.0 x 36mm Polyaxial Screw - M/L Bias |
00840019930994 - Reform POCT System | 2024-04-17 Ø4.0 x 38mm Polyaxial Screw - M/L Bias |