C-Core 40121 Surgical Gown, AAMI IV, STD, Lge, Set in- 40121

GUDID 00817602021568

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use
Primary Device ID00817602021568
NIH Device Record Key58d16efd-a61c-4bdb-9eea-197fa19b7d57
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-Core 40121 Surgical Gown, AAMI IV, STD, Lge, Set in-
Version Model Number40121
Catalog Number40121
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817602021551 [Primary]
GS100817602021568 [Package]
Contains: 00817602021551
Package: Case [40 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 Date2016-09-27

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00850015378331 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x80cm with tape closure
00850015378355 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 12x100cm with tape closure
00850015378386 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x120cm with tape closure
00850015378416 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x100cm with tape closure
00850015378447 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 20x110cm with tape closure
00850015378478 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x90cm with tape closure

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