E5460/N Band Bag with tape 91x76cm- 36"x30"

GUDID 00816953027014

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile
Primary Device ID00816953027014
NIH Device Record Key317d56ac-ec5f-40e8-8e49-9fb056fac5c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameE5460/N Band Bag with tape 91x76cm- 36"x30"
Version Model NumberE5460/N
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816953027007 [Primary]
GS100816953027014 [Package]
Contains: 00816953027007
Package: Inner Case [43 Units]
In Commercial Distribution
GS100816953027021 [Package]
Contains: 00816953027007
Package: Case [86 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 Number3
Public Version Date2018-07-06
Device Publish Date2016-11-11

On-Brand Devices [E5460/N Band Bag with tape 91x76cm- 36"x30"]

00816953027045E5460/N
00816953027014E5460/N

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