Exact Medical E6707

GUDID 00850031271234

Cover for Vision System 62x300cm

EXACT MEDICAL MANUFACTURING, INC.

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Primary Device ID00850031271234
NIH Device Record Key7a6203c6-de35-4d7a-9f36-5006c2416262
Commercial Distribution StatusIn Commercial Distribution
Brand NameExact Medical
Version Model NumberE6707
Catalog NumberE6707
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exempttrue
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850031271227 [Primary]
GS100850031271234 [Package]
Contains: 00850031271227
Package: inner case [25 Units]
In Commercial Distribution
GS100850031271241 [Package]
Package: Case [1 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

On-Brand Devices [Exact Medical]

00850024023130Robot Arm Sterile Drape
00816953022545Band Bag with Tape & Elastic 91x91cm
00850024023215Microscope Drape, Leica, Bayonet, 137x381cm - 54" x 150"
00850024023321Robot Arm Sterile Drape
00850024023529Arthroscopy Surgical T-Drape with Fluid Control Pouch
00850024023505Under Buttock Drape w Pouch & Backing
00850024023482Lithotomy Pack
00850024023468Abdominal Pack
00850024023444Universal Split Pack
00850024023420Universal Pack
00850024023581Gown, Surgical AAMI Level 4 XX-Large w/ Towel
00850024023567Gown, Surgical AAMI Level 4 X-Large w/ Towel
00850024023543Gown, Surgical AAMI Level 4 Large w/ Towel
00850024023604Drape for VITOM® Eagle
00850024023741Drill Cover, cardboard insert, 8.5x175cm 3.3"x69"
00850024023727Band Bag Nose Shape 89x120cm - 35"x47"
00850031271029Band Bag, nose shaped, 80cm x 45cm - 32'' x 18''
00850024023888Band Bag 85cmx150cm - 34"x 59"
00850024023864Microscope Drape, Zeiss MD, 117x203cm - 46"x80"
00850024023826Universal Handle Cover Microscope pack of 2
00850024023802Microscope Drape, Zeiss MD, 117x305cm - 46"x120"
00850024023765Camera Drape, Perf.Tip, Cardboard Insert, 18x244cm - 7"x96"
00850031271074Dome Bag 90 cm - 35"
00850031271098Stockinette 16x121cm - 6" x 48"
00850031271210Stockinette, Rolled, Stretchable 30x121cm
00850031271234Cover for Vision System 62x300cm

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