E6552N SMS Shorts for Colonoscopy Extra Large E6552N

GUDID 00852205007137

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use
Primary Device ID00852205007137
NIH Device Record Key6f936855-6528-4003-80f9-e66644438f9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameE6552N SMS Shorts for Colonoscopy Extra Large
Version Model NumberE6552N
Catalog NumberE6552N
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 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
GS100852205007120 [Primary]
GS100852205007137 [Package]
Contains: 00852205007120
Package: Case [210 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-10-07

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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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