FDA.report

Lap Sponge, Sterile, Pre-Washed

Primary DI
00616784314532
Brand
Lap Sponge, Sterile, Pre-Washed
Company
DYNAREX CORPORATION
Model
3145
Device description
Lap Sponge, Sterile, Pre-Washed, 12"x12", X-Ray Detectable- 5ct.
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
00616784314532PackageGS140In Commercial Distribution
00616784314525PrimaryGS10
00616784314518Unit of UseGS10
00810180844062Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784314532006167843145326167843145320616784314532
00616784314525006167843145256167843145250616784314525
00616784314518006167843145186167843145180616784314518
00810180844062008101808440628101808440620810180844062

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
5
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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