Exact Medical Manufacturing E6463

GUDID 16975424194868

Probe Cover, PE,Tape tip,Gel & Elastic bands 18x28cm-7"x11"

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover
Primary Device ID16975424194868
NIH Device Record Key4f292838-9434-421a-a935-e4297034101d
Commercial Distribution StatusIn Commercial Distribution
Brand NameExact Medical Manufacturing
Version Model NumberE6463
Catalog NumberE6463
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975424194861 [Primary]
GS116975424194868 [Package]
Contains: 06975424194861
Package: Inner Case [20 Units]
In Commercial Distribution
GS126975424194865 [Package]
Package: Case [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-22
Device Publish Date2024-07-12

On-Brand Devices [Exact Medical Manufacturing]

00852205007847E5937
20852205007971Microscope Drape-Leica, Bayonet, 137x381cm - 54"x150"
10852205007950Sterile Dual Fenstrated Drape
00852205007946Microscope Drape, Leica 137x381cm – 54” x 150”
00852205007915EP5512
00850015378294Probe Cover, 14 x 29.2, Kit, VIP Film w/ Elastic Bands & EMM Gel
00850015378539Surgical Gown, Large, AAMI 4 HaloGuard
00850024023017C-Arm Drape 107x165cm
00850033380606Sheet 140cmx140cm Kit Pack Fold
00850033380583Sheet 140cmx140cm Fan Fold
00850033380569Sheet 120cmx120cm Kit Pack Fold
00850033380545Sheet 120cmx120cm Fan Fold
00850033380521Sheet 90cmx90cm Kit Pack Fold
00850033380507Sheet 90cmx90cm Fan Fold
00850033380620Micromate Needle Guide Set/Device Cover PE w Needle Guide 8G-11G Elastic Band 35x110cm
00850033380675Femoral Drape 220x380cm
00850033380651Reinforced BTC
00850033380712Robot Drape
00850033380743Screen Cover with cuff 34x76cm
00850033380767Dome Bag 18cm - 7"
00850033380781C-Arm Drape with Clips 41x230cm - 16"x91"
00850033380811Drape, PU, 60x60cm round fen 6cm with Adhesive
00816953024358C-Arm Drape 224X107cm - 88"x42"
00850033380842Probe Cover, VIP film, Gel, Elastic bands 15x91cm - 6"x36"
10850033380887Sponge Counter Bag Rack
00850037124008Drape 90x90cm, Fenestration 10cm round ADH, Bi-Laminate
00850037124022C-Arm Kit XLVI (46)
06975085709206Micromate Tracker and Drape
16975085708534Micromate Needle Guide Set/Device Cover PE w Needle Guide 8G-11G Elastic Band 35x110cm
16975085708817Probe Cover, PE, Gel and Elastic bands, 6"x96"
16975085708503Drape for VITOM® eagle (TH201)
26975085708357Surgical Gown, X-Large, Fabric Reinf. AAMI 3
26975085708340Surgical Gown, Large, Fabric Reinf. AAMI 3
16975085706103Sterile Drape CCU 25cm wide x 100cm long
16975085706073Device Cover PE w Needle Guide 11G-14G Elastic Band 35x110cm
16975085706066Device Cover PE w Needle Guide 15G-21G Elastic Band 35x110cm
16975424191515Probe Cover Polyurethane
16975424191508Probe Cover Polyurethane
16975085703744EXPLORER AIR® Sterile Drape
16975424193359Probe Cover, VIP film, Gel & Elastic bands 15x122cm-6"x48"
16975424193342Probe Cover, PE, Gel and Elastic bands 15x122cm, 6"x48"
16975424194554Micromate Control Unit Drape
16975424194547Micromate Needle Guide 8-11G
16975424194530Micromate Needle Guide 15-21G
16975424194523Micromate Needle Guide 10-14G
26975424194612Hemorrhage View C-Section Drape, sterile
16975424195285Foot Switch Cover with drawstring 36x76cm - 14"x30"
26975424195251Hemorrhage View C-Section Drape,Sterile, full incision panel
26975424195237Hemorrhage View C-Section Drape, Sterile, Pear Shaped fenestration within incision panel
16975424195391Remote Control Cover 125x260mm

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