Exact Medical Manufacturing, Inc.

GUDID 06975085709183

Cover IID 168x60cm

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use
Primary Device ID06975085709183
NIH Device Record Key325ee706-c0f3-4d58-8411-292602b3d4c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameExact Medical Manufacturing, Inc.
Version Model NumberE6784
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975085709183 [Primary]
GS116975085709180 [Package]
Package: Inner Case [50 Units]
In Commercial Distribution
GS126975085709187 [Package]
Contains: 16975085709180
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 Date2023-05-02
Device Publish Date2023-04-24

On-Brand Devices [Exact Medical Manufacturing, Inc.]

06975085709183Cover IID 168x60cm
16975424196183Robotic assistant surgical cover
26975424196166Sterile Cover with perforated tip 5" x 96"
16975424196480C-Arm B Model Ziehm VI (6)
16975424196459Cover IID 168x60cm
06975424193420Multipurpose, Weighted Surgical Towel, Single
26975424196548UNIVERSAL MINI C-ARM DRAPE
16975424196497Probe Cover, Polyurethane
16975085701078Drape 100x150cm, 2L
16975085701016Drape, 200x150cm, PE
26975085700658Gown , PRF with 2 Towels , XL , SMS
26975085700634Gown , PRF with 2 Towels , L , SMS
06975085700531Surgical Gown XX-Large Poly Reinforced
26975085700528Surgical Gown X-Large Poly Reinforced
06975085700241Gown , Standard with 2 Towels , L , SMS
26975085700221Gown , Standard with 2 Towels , XL , SMS
26975085700184Gown , Standard with 2 Towels , Large , Phoenix
26975424196531Triple Wide Orange Cover
26975424196524Double Wide Orange Cover
26975424195640Drape for Zeiss Surgical Microscope w. LensGuard 54'' x 150"
1697542419553768mm Leica Lens M/S Four Oculars 54"x150" Angled Glass Lens
16975424195520Leica MS Drape w/ Angled Glass Lens 54"x150"
16975424195513Leica MS Drape w/ Angled Glass Lens 54"x120"
16975424195506Microscope Drape for Zeiss MD 65mm Glass Lens, 54"x150"
26975424196159OEC Elite MiniView C-Arm Drape – 36 in x 100 in, 91cm x 253c
16975424196039Cover, Holding Systems PE
26975424195824Dome Bag 18"
26975424195817C-Arm X-Ray Tube Cover
26975424195800Mini C-Arm Drape 52"x72"
26975424195794C-Arm Drape 41" x 74"
26975424195749Microscope Drape - Zeiss MD 54" x 150" - 137cm x 381cm
269754241957327" x 96", Open End, Closed Sys. Cam/Video Drape, w/ PS & Adh
16975424195728MS DR F/Zeiss MD 54" x 120" w/Glass Lens
26975424195718Zeiss Microscope Drape, 54" x 150", 6.5w/ HLT Ang. Lens, NC4
16975424195704Screen Cover
16975424195698Robot Drape 200x50cm with two elastic bands
16975085704352Probe Cover, VIP film, Gel, El.b, Cardb. 15x61cm
16975085703454C-Arm Tube Film 193x30cm-76x12"
26975424196579Hemorrhage View C-Section Drape, Sterile, Pear Shp
26975424196555Hemorrhage View C-Section Drape, Sterile, full Inc Panel
16975424195971Probe Cover (Flat End) W/Gel & Bands 5.5" x 48"
16975424195964Probe Cover, PE,Tape tip,Gel & Elastic bands 18x28cm-7"x11"
16975424195940Ivoclar Cover with Elastic bands, folded
26975424195886Two-Tier Backtable Cover HD 183cm - 72"
26975424195879Ophthalmic Full Body Drape 183cm x 292cm - 72" x 115"
26975424195862Fenestrated Drape with Linear Tear Technology - 89x127cm
26975424195855Incise Drape 45cm x 55cm - 18" x 22"
26975424195848Incise Drape, 16x19cm, Adhesive Area 10x19cm
1697542419631226975424196319 EM SIDE EMITTER DRAPE 9736701
16975424196251Intraoperative Probe Cover w/Gel 6" x 96" (14cm x 244cm) non

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