Screwdriver HexaDrive 265497

GUDID 05712149027408

Screwdriver HexaDrive. Consists of blade (DM DI 05712149027415) and handle (DM DI 057121490274225).

Oticon Medical AB

Surgical screwdriver, reusable
Primary Device ID05712149027408
NIH Device Record Key96ccc30e-603b-4b9e-9343-dabccdd9aa5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameScrewdriver HexaDrive
Version Model Number265497
Catalog Number265497
Company DUNS554563994
Company NameOticon Medical AB
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 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

Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com
Phone888-277-8014
Emailinfo@oticonmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105712149027408 [Primary]
GS105712149027415 [Direct Marking]

FDA Product Code

LRCInstrument, Ent Manual Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


[05712149027408]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-24
Device Publish Date2024-06-14

Devices Manufactured by Oticon Medical AB

05712149027590 - Genie Medical2024-08-16 SALES PACK, GENIE MEDICAL BAHS 2024.2 USB
05712149027637 - Genie Medical2024-08-16 ISO FILE, GENIE MEDICAL BAHS 2024.2 US VA
05712149027644 - Genie Medical2024-08-16 FLEX LINK GENIE MEDICAL BAHS 24.2
05712149025459 - Sentio2024-07-30 SENTIO 1 MINI, CBE
05712149025466 - Sentio2024-07-30 SENTIO 1 MINI, TC
05712149025473 - Sentio2024-07-30 SENTIO 1 MINI, SIL
05712149025480 - Sentio2024-07-30 SENTIO 1 MINI, STG
05712149025497 - Sentio2024-07-30 SENTIO 1 MINI, CNB

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