Exact Memdical Manufacturing EP54-120

GUDID 20852205007964

Microscope Drape-Leica, Bayonet, 137x305cm - 54"x120"

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile
Primary Device ID20852205007964
NIH Device Record Key9c622bb2-1d13-4ffe-a636-b8e963fa4b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameExact Memdical Manufacturing
Version Model NumberEP54-120
Catalog NumberEP54-120
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100852205007960 [Primary]
GS110852205007967 [Package]
Contains: 00852205007960
Package: Inner Case [10 Units]
In Commercial Distribution
GS120852205007964 [Package]
Contains: 10852205007967
Package: Outer Case [1 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 Date2018-10-08
Device Publish Date2018-09-06

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

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26975424198320 - Exact Medical Manufacturing, Inc.2025-12-11 Urological Drain Bag - Siemens Table, 8mm Adaptor
26975424198344 - Exact Medical Manufacturing, Inc.2025-12-11 Uro-Catcher Bag - Fits All Hoop Style Frames, 8mm Adaptor
26975424198368 - Exact Medical Manufacturing, Inc.2025-12-11 Uro-Catcher Bag - Fits All Hoop Style Frames, 6mm Adaptor
26975424198382 - Exact Medical Manufacturing, Inc.2025-12-11 Urological Drain Bag - GE/OEC UroView 2600/2800 w/ Covers
26975424198535 - Exact Medical Manufacturing, Inc.2025-12-04 Leica Microscope Drape 46” x 80”, Bayonet with Drawcord

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