Batrik Level 2 Ultrasonically WeldedSeam\Blue Gown\Size M SF-202-M

GUDID 00690521018075

Level 2 Protective Gowns, Medium, Blue

Batrik Medical Manufacturing Inc

Isolation gown, single-use
Primary Device ID00690521018075
NIH Device Record Key10fc7dc6-50f4-4b0b-aec3-e652efb7b8b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBatrik Level 2 Ultrasonically WeldedSeam\Blue Gown\Size M
Version Model NumberSF-202-M
Catalog NumberSF-202-M
Company DUNS243880700
Company NameBatrik Medical Manufacturing Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com
Phone514-631-7988
Emailinfo@surmed.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100690521018075 [Primary]

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-04
Device Publish Date2022-01-27

Devices Manufactured by Batrik Medical Manufacturing Inc

00690521011526 - NON-STERILE Biopsy Valve Covers 2024-10-16 Biopsy Valve Covers – Blue - Olympus® & Fujinon®
00690521011533 - NON-STERILE Biopsy Valve Covers 2024-10-16 Biopsy Valve Covers – Red - Pentax®
00690521020672 - NON-STERILE Biopsy Valve Covers 2024-10-16 Biopsy Valve Cover - Olympus & Fujinon - Blue
00690521020689 - NON-STERILE Biopsy Valve Covers 2024-10-16 Biopsy Valve Cover - Pentax - Pink
00690521013612 - Sharn Brushes2024-09-20 Frazier (Baron) Brush 10" / 250mm, 3FR
00690521013629 - Sharn Brushes2024-09-20 Fraizer Baron Brush 10inch, 250mm, 5FR
00690521013636 - Sharn Brushes2024-09-20 Frazier (Baron) Brush 10" / 250mm, 6FR
00690521013643 - Sharn Brushes2024-09-20 Frazier (Baron) Brush 10" / 250mm, 7FR

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