C-Core 30151B SMS Surgical Gown STD X-Lge, X-Lng, Set in- 30151B

GUDID 00817602021421

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile
Primary Device ID00817602021421
NIH Device Record Key289043b5-0bae-48d5-a2e4-9340e4f0d645
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-Core 30151B SMS Surgical Gown STD X-Lge, X-Lng, Set in-
Version Model Number30151B
Catalog Number30151B
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817602021414 [Primary]
GS100817602021421 [Package]
Contains: 00817602021414
Package: Case [32 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 Date2016-09-26

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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