SPECIALTY CAP DRIVER

GUDID 08800247360026

Innosys Co., Ltd.

Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver
Primary Device ID08800247360026
NIH Device Record Key7b737ac4-fb93-4681-893a-79f88ff2c000
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPECIALTY CAP DRIVER
Version Model NumberFCS1008
Company DUNS688811082
Company NameInnosys Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800247360026 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800247360026]

Moist Heat or Steam Sterilization


[08800247360026]

Moist Heat or Steam Sterilization


[08800247360026]

Moist Heat or Steam Sterilization


[08800247360026]

Moist Heat or Steam Sterilization


[08800247360026]

Moist Heat or Steam Sterilization


[08800247360026]

Moist Heat or Steam Sterilization


[08800247360026]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-15
Device Publish Date2024-04-05

Devices Manufactured by Innosys Co., Ltd.

08800247360088 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06
08800247360095 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06
08800247360101 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06
08800247360118 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06
08800247360125 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06
08800247360132 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06
08800247360149 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06
08800247360156 - ANAX™ 5.5 SPINAL SYSTEM2024-05-06

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