MakoMed MM2000

GUDID 16975424191317

Probe Cover , VIP film , Gel and Elastic Bands 13x61cm

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover
Primary Device ID16975424191317
NIH Device Record Key0767e111-e9b0-4b7d-95b2-b6eedb0ce550
Commercial Distribution StatusIn Commercial Distribution
Brand NameMakoMed
Version Model NumberMM2000
Catalog NumberMM2000
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
GS106975424191310 [Primary]
GS116975424191317 [Package]
Contains: 06975424191310
Package: Case [30 Units]
In Commercial Distribution
GS126975424191314 [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 Date2023-04-12
Device Publish Date2023-04-04

On-Brand Devices [MakoMed]

16975424191355Band Bag with tape 127x91cm- 50"x36"
16975424191348Band Bag with Tape and Elastic Bands 91x91cm
16975424191331Band Bag with Tape and Elastic Bands 91x56 cm - 36" x 22"
16975424191324Probe Cover , VIP film , Gel and Elastic Bands 13x122cm
16975424191317Probe Cover , VIP film , Gel and Elastic Bands 13x61cm
16975424191300Microscope Drape - Zeiss MD 117x203cm
16975424191294Microscope Drape - Leica 137 x 381 cm
16975424191287Microscope Drape- Zeiss MD, 137x381cm - 54"x150"

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