Defries Industries DEF2409

GUDID 00850033380989

Ultrasound Probe Cover 26cm x 1.5m (Sealed End) with Elastic Bands

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover
Primary Device ID00850033380989
NIH Device Record Key2a2749b4-e01d-4fa2-9db1-d20c352e21c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDefries Industries
Version Model NumberDEF2409
Catalog NumberDEF2409
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
GS100850033380972 [Primary]
GS100850033380989 [Package]
Contains: 00850033380972
Package: Case [80 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 Date2021-12-17
Device Publish Date2021-12-09

On-Brand Devices [Defries Industries]

00850033380989Ultrasound Probe Cover 26cm x 1.5m (Sealed End) with Elastic Bands
00850033380965Ultrasound Probe Cover Sealed End 23cm x 80cm
00850033380941Drawstring Probe Cover 23cm x 1.5m
00850033380927Drawstring Probe Cover 23cm x 1m
00850033380897Ultrasound Probe Cover 23cm x 1.5m

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.