FDA.reportPublic FDA data

RELIAMED

Primary DI
50888499000566
Brand
RELIAMED
Company
RGH ENTERPRISES
Model
ZGB44
Catalog number
ZGB44
Device description
ReliaMed Sterile Bordered Gauze Dressing 4" x 4"
Published
2019-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888499000565PackageGS125In Commercial Distribution
50888499000566PackageGS118In Commercial Distribution
00888499000561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088849900056520888499000565
5088849900056650888499000566
00888499000561008884990005618884990005610888499000561

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049735438
Device count
1
DM exempt
false
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
false
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
00888499000523RELIAMEDZGB235ZGB2352019-05-17
00888499000530RELIAMEDZGB410ZGB4102019-05-17
00888499000547RELIAMEDZGB414ZGB4142019-05-17
00888499000561RELIAMEDZGB44ZGB442019-05-17
00888499000578RELIAMEDZGB46ZGB462019-05-17
00888499000585RELIAMEDZGB48ZGB482019-05-17
00888499000592RELIAMEDZGB66ZGB662019-05-17
00888499000608RELIAMEDZGC44ZGC442019-05-17
00888499000615RELIAMEDZGC66ZGC662019-05-20
00888499000622RELIAMEDZGFB44ZGFB442019-05-17
10885380122712CARDINAL HEALTH ESSENTIALSZTDR02ZTDR022019-05-22
10885380122729CARDINAL HEALTH ESSENTIALSZTDR04ZTDR042019-05-22
10885380122736CARDINAL HEALTH ESSENTIALSZTDR06ZTDR062019-05-22
00885380122548CARDINAL HEALTH ESSENTIALSZTSC08ZTSC082019-04-22
00885380122555CARDINAL HEALTH ESSENTIALSZTPA05AZTPA05A2019-05-22
00885380122562CARDINAL HEALTH ESSENTIALSZTPL05AZTPL05A2019-05-22
00885380122579CARDINAL HEALTH ESSENTIALSZTCL05AZTCL05A2019-05-22
00885380122685CARDINAL HEALTH ESSENTIALSZTCL01AZTCL01A2019-05-22
00885380122692CARDINAL HEALTH ESSENTIALSZTCL02AZTCL02A2019-05-22
00885380122708CARDINAL HEALTH ESSENTIALSZTCL03AZTCL03A2019-05-22

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040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
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05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
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