C-Core 60022C Set-up Pack I- 60022C

GUDID 00817602022268

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile
Primary Device ID00817602022268
NIH Device Record Key29eb0007-4842-49e5-a5cc-8f4c1a234e5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-Core 60022C Set-up Pack I-
Version Model Number60022C
Catalog Number60022C
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 Perscriptionfalse
OTC Over-The-Countertrue

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
GS100817602022251 [Primary]
GS100817602022268 [Package]
Contains: 00817602022251
Package: Case [44 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 Date2016-09-27

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

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16975085709494 - Cyber Surgery2024-07-22 Robotic assistant surgical cover
16975424194868 - Exact Medical Manufacturing2024-07-22 Probe Cover, PE,Tape tip,Gel & Elastic bands 18x28cm-7"x11"
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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