G912107

GUDID 00841379104520

G10 EGG, RATCHET, 1/4 SQ. SECURE SHAFT, CANNULATED

HYHTE HOLDINGS, INC.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID00841379104520
NIH Device Record Key53cfe16d-4e03-49bc-9e21-8d78d434fa94
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberG912107
Catalog NumberG912107
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379104520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


[00841379104520]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-25
Device Publish Date2019-07-17

Devices Manufactured by HYHTE HOLDINGS, INC.

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00840085254420 - NA2024-05-07 POLYAXIAL, HIGH TOP, TULIP
00840085254437 - NA2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
00840085254444 - NA2024-05-07 FAVORED ANGLE M/L, TULIP
00840085254451 - NA2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
00840085254468 - NA2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
00840085254475 - NA2024-05-07 FAVORED ANGLE C/C, TULIP
00840085254482 - NA2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP

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