FDA.reportPublic FDA data

EAR DRESSING, PEDIATRIC

Primary DI
10850000126142
Brand
EAR DRESSING, PEDIATRIC
Company
Oto-Med, Inc.
Model
S-1003
Device description
EAR DRESSING, PEDIATRIC
Published
2020-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850000126142PackageGS16In Commercial Distribution
00850000126145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000012614210850000126142
00850000126145008500001261458500001261450850000126145

GMDN Terms#

Term, Definition table
TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
059817742
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000126077spineX BONE DUST COLLECTORS-45002018-09-21
00850000126169CI UNIVERSAL DRAPESD-23002021-11-19
00850000126084GLASSCOCK OTOLOGY SURGERY DRAPESD-21002018-09-21
00850000126091GLASSCOCK NEUROTOLOGY SURGERY DRAPESD-22002018-09-21
10850000126166CI UNIVERSAL DRAPESD-23002021-11-19
00850000126121OTOMED® SUCTION TUBINGSP-40002018-09-21
00850000126152LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
10850000126159LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
00850000126015GLASSCOCK® EAR DRESSING, ADULTS-10002018-09-21
00850000126022GLASSCOCK® EAR DRESSING, PEDIATRICS-10032018-09-21
00850000126046SHEEHY BONE DUST COLLECTORS-25002018-09-21
00850000126060COX BONE DUST COLLECTORS-35002018-09-21
00850000126138EAR DRESSING, ADULTS-10002020-11-30
00850000126145EAR DRESSING, PEDIATRICS-10032020-11-30
10850000126135EAR DRESSING, ADULTS-10002020-11-30
00850000126039HEAD & NECK PRESSURE DRESSINGS-1010-22018-09-21
00850000126114LEVINE IRRIGATION-SUCTION KITSP-30002018-09-21
00850000126053SHEEHY-HOUSE POWDER INSUFFLATORS-30012018-09-21
00850000126107SAFETRAP TISSUE COLLECTORSP-20002018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68932700080BATTLE BANDAGESafeguard US Operating, LLCMHW2025-08-01
10884450828752SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-07-01
10884450844240SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-03-07
M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
10884450828745SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
00810041983572ViveVIVE HEALTH LLCMHW2024-06-07
00810041983589ViveVIVE HEALTH LLCMHW2024-06-07
00810041983596ViveVIVE HEALTH LLCMHW2024-06-07
00810041983602ViveVIVE HEALTH LLCMHW2024-06-07
00810041983619ViveVIVE HEALTH LLCMHW2024-06-07
00810041982087ViveVIVE HEALTH LLCMHW2024-06-05
00840117327825"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Green"Dynarex CorporationMHW2023-12-20
00840117327849"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Light Blue"Dynarex CorporationMHW2023-12-20
00840117327863"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple "Dynarex CorporationMHW2023-12-20
00840117327887"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Pink"Dynarex CorporationMHW2023-12-20
00840117327900"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Red"Dynarex CorporationMHW2023-12-20
00840117327924"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green"Dynarex CorporationMHW2023-12-20
00840117327726"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Green"Dynarex CorporationMHW2023-12-17
00840117327740"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue"Dynarex CorporationMHW2023-12-17
00840117327764"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple "Dynarex CorporationMHW2023-12-17
00840117327788"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink"Dynarex CorporationMHW2023-12-17
00840117327801"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Red "Dynarex CorporationMHW2023-12-17
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
10811331010180Comfort BandTz Medical, Inc.MHW2023-10-20
00810113571249ViveVIVE HEALTH LLCMHW2023-08-07
00810113571256ViveVIVE HEALTH LLCMHW2023-08-07
00810113571959ViveVIVE HEALTH LLCMHW2023-08-07
00810113571966ViveVIVE HEALTH LLCMHW2023-08-07
00810113571973ViveVIVE HEALTH LLCMHW2023-08-07