FDA.report

X-Ray Detectable Surgical Gauze Sponge

Primary DI
00616784335131
Brand
X-Ray Detectable Surgical Gauze Sponge
Company
DYNAREX CORPORATION
Model
3351
Device description
X-Ray Detectable Surgical Gauze Sponge, 16 Ply, Sterile 4"x4"; All Gauze USP, Type VII
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
true
Single use
true

Related Records

Product Codes

CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784335131PackageGS1128In Commercial Distribution
00616784335117PrimaryGS10
00616784335100Unit of UseGS10
00810180844291Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784335131006167843351316167843351310616784335131
00616784335117006167843351176167843351170616784335117
00616784335100006167843351006167843351000616784335100
00810180844291008101808442918101808442910810180844291

GMDN Terms

TermDefinition
Radiopaque non-woven surgical sponge, sterileA non-medicated sterile device made from a non-woven absorbent material (e.g., rayon/polyester) 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, it may also be used for prepping the patient. It is intended to produce less lint than woven gauze and contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
10
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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