Instrument Organizer

GUDID 00850071154450

Hanes Companies, Inc.

Surgical instrument guard, single-use
Primary Device ID00850071154450
NIH Device Record Key15300822-e578-4227-a0e4-91af8b624d69
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrument Organizer
Version Model NumberCSDH512
Company DUNS139362420
Company NameHanes Companies, Inc.
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
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
GS100850071154436 [Primary]
GS100850071154450 [Unit of Use]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-12-08
Device Publish Date2025-10-22

Devices Manufactured by Hanes Companies, Inc.

00850071154450 - Instrument Organizer2025-12-08
00850071154450 - Instrument Organizer2025-12-08
00850071154061 - Steri-Pocket2025-07-24
00850071154108 - Steri-Pocket2025-07-24
00850071154122 - Steri-Pocket2025-07-24
00850071154146 - Steri-Pocket2025-07-24
00850071154160 - Steri-Pocket2025-07-24
00850071154184 - Steri-Pocket2025-07-24
00850071154085 - Steri-Pocket2025-07-24

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