Coulmed DI-1415

GUDID 00850024023925

Double Back Table Cover 5'

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use
Primary Device ID00850024023925
NIH Device Record Keyf0a4e0ad-1657-4a37-a81d-751394c81a30
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoulmed
Version Model NumberDI-1415
Catalog NumberDI-1415
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850024023918 [Primary]
GS100850024023925 [Package]
Contains: 00850024023918
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [Coulmed]

00850003355290Half-Bag C-Arm Cover 36”x80”
00850003355351Coulmed C-Sheet Standard 137x81cm- 54"x32"
00850003355337Coulmed Double Back Table Cover 72" Wide
00850003355313Coulmed C-Arm Kit XXIII (equipment covers only)
00850024023987Coulmed Double Back Table Cover 72" Wide
00850024023949Double Back Table Cover 6'
00850024023925Double Back Table Cover 5'
00850024023901Double Back Table Cover 4'

Trademark Results [Coulmed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COULMED
COULMED
76230706 2737954 Live/Registered
MACDOUGALL, MICHAEL, MR.
2001-03-26

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