GLASSCOCK OTOLOGY SURGERY DRAPE

GUDID 00850000126084

GLASSCOCK OTOLOGY SURGERY DRAPE

Oto-Med, Inc.

Patient surgical drape, single-use, sterile
Primary Device ID00850000126084
NIH Device Record Key57a8d044-3bc9-4ec4-ab4b-c7bb1830d754
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLASSCOCK OTOLOGY SURGERY DRAPE
Version Model NumberSD-2100
Company DUNS059817742
Company NameOto-Med, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850000126084 [Primary]
GS110850000126081 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-04
Device Publish Date2018-09-21

Devices Manufactured by Oto-Med, Inc.

10850000126166 - CI UNIVERSAL DRAPE2021-11-29 CI UNIVERSAL DRAPE
10850000126159 - LEVINE IRRIGATION-SUCTION TUBING2021-02-08 LEVINE IRRIGATION-SUCTION TUBING
10850000126135 - EAR DRESSING, ADULT2020-12-08 EAR DRESSING, ADULT
10850000126142 - EAR DRESSING, PEDIATRIC2020-12-08 EAR DRESSING, PEDIATRIC
00850000126015 - GLASSCOCK® EAR DRESSING, ADULT2020-03-13 GLASSCOCK® EAR DRESSING, ADULT
00850000126022 - GLASSCOCK® EAR DRESSING, PEDIATRIC2020-03-13 GLASSCOCK® EAR DRESSING, PEDIATRIC
00850000126039 - HEAD & NECK PRESSURE DRESSING2020-03-13 HEAD & NECK PRESSURE DRESSING
00850000126121 - OTOMED® SUCTION TUBING2019-10-07 OTOMED® SUCTION TUBING
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