AZE030000

GUDID 00841379165262

MIS TARGETING NEEDLE HOLDER

HYHTE HOLDINGS, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00841379165262
NIH Device Record Key38719ed3-d1a3-494d-82f3-a18191e1188e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAZE030000
Catalog NumberAZE030000
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 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

Customer Support Contacts

Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379165262 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


[00841379165262]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-11
Device Publish Date2021-06-03

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085256653 - NA2024-04-16 DUAL LEAD SCREW
00840085256660 - NA2024-04-16 DUAL LEAD SCREW
00840085256677 - NA2024-04-16 DUAL LEAD SCREW
00840085256684 - NA2024-04-16 DUAL LEAD SCREW
00840085256691 - NA2024-04-16 DUAL LEAD SCREW
00840085256707 - NA2024-04-16 DUAL LEAD SCREW
00840085256714 - NA2024-04-16 DUAL LEAD SCREW
00840085256721 - NA2024-04-16 DUAL LEAD SCREW

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.