KZA09SQ04

GUDID 00840085214530

PITUITARY, STRAIGHT #4, SERRATED

HYHTE HOLDINGS, INC.

Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable
Primary Device ID00840085214530
NIH Device Record Key65e985ef-e7b9-4f98-8f38-548a86be50cb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberKZA09SQ04
Catalog NumberKZA09SQ04
Company DUNS073029645
Company NameHYHTE HOLDINGS, INC.
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

Customer Support Contacts

Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085214530 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085214530]

Moist Heat or Steam Sterilization


[00840085214530]

Moist Heat or Steam Sterilization


[00840085214530]

Moist Heat or Steam Sterilization


[00840085214530]

Moist Heat or Steam Sterilization


[00840085214530]

Moist Heat or Steam Sterilization


[00840085214530]

Moist Heat or Steam Sterilization


[00840085214530]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-11
Device Publish Date2021-08-03

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085201844 - NA2021-08-11 AXIAL HANDLE, ML, ADV 1/4 SQ, FIXED, ALUMINUM CORE, EXTERNAL, NON-CANNULATED, SIDE LOADING SLAP CAP
00840085201851 - NA2021-08-11 AXIAL HANDLE, ML, ADV 1/4 SQ, FIXED, ALUMINUM CORE, EXTERNAL, CANNULATED, SIDE LOADING SLAP CAP
00840085201882 - NA2021-08-11 T-HANDLE, L, ADV 1/4 SQ, FIXED, ALUMINUM CORE, EXTERNAL, NON-CANNULATED, S/L SLAP HAMMER CAP
00840085201899 - NA2021-08-11 T-HANDLE, L, ADV 1/4 SQ, FIXED, ALUMINUM CORE, EXTERNAL, CANNULATED, S/L SLAP HAMMER CAP
00840085214424 - NA2021-08-11 BALL TIP PROBE, 90°
00840085214431 - NA2021-08-11 PENFIELD, #4
00840085214448 - NA2021-08-11 LEXCEL RONGEUR, SERRATED
00840085214530 - NA2021-08-11PITUITARY, STRAIGHT #4, SERRATED
00840085214530 - NA2021-08-11 PITUITARY, STRAIGHT #4, SERRATED

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