FDA.report

Advantage Surgical Sponge

Primary DI
00616784326337
Brand
Advantage Surgical Sponge
Company
DYNAREX CORPORATION
Model
3263
Device description
Advantage Surgical Sponges, 3"x3", 12 Ply
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784326337PackageGS120In Commercial Distribution
00616784326320PrimaryGS10
00616784326313Unit of UseGS10
00810180844222Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784326337006167843263376167843263370616784326337
00616784326320006167843263206167843263200616784326320
00616784326313006167843263136167843263130616784326313
00810180844222008101808442228101808442220810180844222

GMDN Terms

TermDefinition
General-purpose surgical spongeA non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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