Laparotomy Sponge
Situate - L0836-04P01CN-1
Device Description
A non-medicated device made from woven gauze (e.g., 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, it may also be used for prepping the patient. It 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.
Environmental Conditions
- 1.06
- 0.50
- 90.00
- 10.00
- 140.00
- -22.00
- Keep dry
- 1.06
- 0.70
- 90.00
- 20.00
- 104.00
- 50.00
Device Sizes
- Length: 36 Inch
- Width: 8 Inch
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GDY
Device Name: Gauze/Sponge, Internal, X-Ray Detectable
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.4450
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 20884521706931
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521706934
Package Quantity: 2
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521706934
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 30884521706938
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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