OTOSILK™ Graft Dressing OT-4601

GUDID EBESOT46011

Size: 100 x 150 mm; Type: Nylon

BOSTON MEDICAL PRODUCTS, INC.

Wound-nonadherent dressing, permeable
Primary Device IDEBESOT46011
NIH Device Record Keyc7b1450c-21e9-4434-ad60-c35ac2cb3a52
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTOSILK™ Graft Dressing
Version Model NumberOT-4601
Catalog NumberOT-4601
Company DUNS131855157
Company NameBOSTON MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Customer Support Contacts

Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com
Phone1-800-433-2674
Emailinfo@bosmed.com

Device Dimensions

Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter
Width150 Millimeter
Length100 Millimeter

Operating and Storage Conditions

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
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
HIBCCEBESOT46010 [Primary]
HIBCCEBESOT46011 [Package]
Contains: EBESOT46010
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NABGauze/Sponge,Nonresorbable For External Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-20

On-Brand Devices [OTOSILK™ Graft Dressing]

EBESOT46011Size: 100 x 150 mm; Type: Nylon
34063107102449Size: 100 x 150 mm; Type: Nylon

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