| Primary Device ID | 00841379186915 | 
| NIH Device Record Key | 4ab1566d-51ae-4c50-81b9-23762e1cfd97 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | N/A | 
| Version Model Number | GZB13AN05 | 
| Catalog Number | GZB13AN05 | 
| Company DUNS | 073029645 | 
| Company Name | HYHTE HOLDINGS, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| 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 | 
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | |
| Phone | 760-814-8047 | 
| troy@asturamedical.com | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00841379186915 [Primary] | 
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
[00841379186915]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-07-21 | 
| Device Publish Date | 2021-07-13 | 
| 00841379164388 | TLIF SPACER | 
| 00841379164371 | TLIF SPACER | 
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| 00841379164036 | TLIF SPACER | 
| 00841379139898 | OTLIF SPACER, PEEK, 10MMX22MMX08MMX5°, NON-STERILE | 
| 00841379100614 | OTLIF SPACER, PEEK, 10MMX22MMX14MMX5°, NON-STERILE | 
| 00841379100607 | OTLIF SPACER, PEEK, 10MMX22MMX13MMX5°, NON-STERILE | 
| 00841379100584 | OTLIF SPACER, PEEK, 10MMX22MMX11MMX5°, NON-STERILE | 
| 00841379100577 | OTLIF SPACER, PEEK, 10MMX22MMX10MMX5°, NON-STERILE | 
| 00841379100560 | OTLIF SPACER, PEEK, 10MMX22MMX09MMX5°, NON-STERILE | 
| 00841379100553 | OTLIF SPACER, PEEK, 10MMX22MMX07MMX5°, NON-STERILE | 
| 00841379100546 | TLIF SPACER | 
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