E2049 Vertical Isolation Drape 330X244cm - 130"x96" E2049

GUDID 00816953020534

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile
Primary Device ID00816953020534
NIH Device Record Key10d062d2-29a0-4a3a-bf48-6c4a413255bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameE2049 Vertical Isolation Drape 330X244cm - 130"x96"
Version Model NumberE2049
Catalog NumberE2049
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exemptfalse
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816953020527 [Primary]
GS100816953020534 [Package]
Contains: 00816953020527
Package: Case [12 Units]
In Commercial Distribution
GS100816953022002 [Package]
Contains: 00816953020527
Package: Case [6 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-10-10

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

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26975424195541 - OSIS Medical2024-07-04 OSIS DRAPE - LEICA MICROSCOPE - HANDLES - 5"X10"
16975424195551 - OSIS Medical2024-07-04 OSIS DRAPE - LEICA MICROSCOPE - LARGE - 54"X150"
16975424195568 - OSIS Medical2024-07-04 OSIS DRAPE - LEICA MICROSCOPE - MEDIUM - 46"X120"
16975424195575 - OSIS Medical2024-07-04 OSIS DRAPE - LEICA MICROSCOPE - MINI - 46"X80"
16975424192895 - Exact Medical Manufacturing2024-06-17 Keyboard Cover 30x10cm

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