E5101N Cover, Back Table, 140x100cm, PSB (Absorbent Reinforcement) -60x140cm E5101N

GUDID 00816953020893

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use
Primary Device ID00816953020893
NIH Device Record Keyefb5db53-4da0-4a7d-a990-eba1680a725c
Commercial Distribution StatusIn Commercial Distribution
Brand NameE5101N Cover, Back Table, 140x100cm, PSB (Absorbent Reinforcement) -60x140cm
Version Model NumberE5101N
Catalog NumberE5101N
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
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
GS100816953020886 [Primary]
GS100816953020893 [Package]
Contains: 00816953020886
Package: Case [720 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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