FDA.reportPublic FDA data

Rapid Seal

Primary DI
20017276239427
Brand
Rapid Seal
Company
Aso LLC
Model
00017276239423
Catalog number
X003TIB7D5
Device description
Rapid Seal, Antibacterial Wound Gel, 40 uses, 5 tubes, 0.3 FL OZ (8 ml)
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20017276239427PackageGS172In Commercial Distribution
00017276239423PrimaryGS10
60017276239425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001727623942720017276239427
00017276239423000172762394230172762394230017276239423
6001727623942560017276239425

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, home-useA non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied by a layperson at home to superficial wounds (e.g., minor cuts, lacerations, abrasions) to produce a rapid haemostasis by forming a robust plug of gel which is removed after use; it is not intended for severe wounds/emergency situations. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18558234545xx@xx.xx

Regulatory Flags#

DUNS number
152793493
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276237115Crayola0172762371152020-09-20
00017276233933ALL-HEALTH Hydrocolloid Gel Cushions0172762339330172762339332019-03-29
00017276241709Rapid Seal0172762417092026-05-27
00017276230734Emoji0172762307342020-04-30
00017276238709CARE SCIENCE0172762387092022-01-24
00017276240818Bluey0172762408182025-08-13
00017276236378Wonder Woman Antibacterial Bandages0172762363782020-04-29
00017276236538LOL Surprise Antibacterial Bandages0172762365382020-02-28
00017276238617Clear Passage Nasal Strips0172762386172021-11-15
00017276221169Garfield017276221169GAR52932020-09-20
00017276230598CarePak0172762305982020-07-29
00017276231854Careband- EMOJI1842562020-09-27
00017276232820Antibacterial PJ Masks Bandages0172762328202020-02-28
00017276233667ALL-HEALTH Adhesive Bandages0172762336670172762336672019-03-29
00017276233841ALL-HEALTH Hydrocolloid Gel Bandages0172762338410172762338412019-03-29
00017276233865ALL-HEALTH Hydrocolloid Gel Bandages0172762338650172762338652019-03-29
00017276233889ALL-HEALTH Hydrocolloid Gel Bandages0172762338890172762338892019-03-29
00017276233896ALL-HEALTH Hydrocolloid Gel Bandages0172762338960172762338962019-03-29
00017276233902ALL-HEALTH Hydrocolloid Gel Cushions0172762339020172762339022019-03-29
00017276233926ALL-HEALTH Hydrocolloid Gel Cushions0172762339260172762339262019-03-29

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