Situate L1836-04P01C-1

GUDID 20884521701004

Laparotomy Sponge - RF and X-ray Detectable Pre-washed

Covidien LP

Radiopaque woven surgical sponge

• Primary Device ID: 20884521701004
• NIH Device Record Key: d7c5617a-6349-432c-8c68-491b882253b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Situate
• Version Model Number: L1836-04P01C-1
• Catalog Number: L1836-04P01C-1
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch
• Length: 36 Inch
• Width: 18 Inch

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521701007 [Primary]
GS1	20884521701004 [Package]; Contains: 10884521701007; Package: CASE [100 Units]; In Commercial Distribution
GS1	30884521701001 [Unit of Use]

FDA Product Code

• GDY: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-08-24
• Device Publish Date: 2018-09-26

On-Brand Devices [Situate]

• 30884521722259: Sterile Drape For use with Situate Room Scanner; Caution: For Manufacturing, Processing or Repac
• 20884521700779: Gauze-RF and X-ray Detectable USP Type VII, 8 Ply. Caution: For Manufacturing, Processing or Rep
• 20884521709888: OR Towel - RF and X-ray Detectable Green. Caution: For Manufacturing, Processing or Repacking.
• 20884521701066: OR Towel -RF and X-ray Detectable White. Caution: For Manufacturing, Processing or Repacking.
• 20884521701059: OR Towel -RF and X-ray Detectable Blue. Caution: For Manufacturing, Processing or Repacking.
• 10884521705319: Delivery Console 200X
• 10884521705296: Delivery Console 200LD-V
• 20884521700724: Room Scanner For use with the Situate Detection Console 200X
• 10884521700703: Detection Console 200X
• 10884521700666: Delivery Scanner For use with Situate Delivery Console 200LD-V
• 10884521700659: Delivery Console 200LD-V
• 10884521700642: Body Scanner Lite For use with the Situate Detection Console 200E and Console 200X
• 20884521700601: Gauze - RF and X-ray Detectable USP Type VII, 16 Ply
• 10884521709874: Sterile Drape For use with Situate Room Scanner
• 20884521700687: Sterile Drape For use with Situate Extremity Scanner and Delivery Scanner
• 20884521701165: Tonsil Sponge - RF and X-ray Detectable Tape Strung - Cotton Filled
• 20884521700793: Gauze-RF and X-ray Detectable USP Type VII, 12 Ply. Caution: For Manufacturing, Processing or Re
• 20884521721767: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
• 20884521709833: OR Towel - RF and X-ray Detectable Green
• 20884521706948: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
• 20884521706931: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
• 20884521706924: Laparotomy Sponge-RF and X-ray Detectable Unwashed. Caution: For Manufacturing, Processing or Re
• 20884521706917: Laparotomy Sponge-RF and X-ray Detectable Ring. Caution: For Manufacturing, Processing or Repack
• 20884521706900: Laparotomy Sponge-RF and X-ray Detectable No Loop. Caution: For Manufacturing, Processing or Rep
• 20884521706894: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
• 20884521706887: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
• 20884521706870: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
• 20884521706863: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
• 20884521701233: Vaginal Packing - RF and X-ray Detectable Folded
• 20884521701226: Vaginal Packing - RF and X-ray Detectable Folded
• 20884521701219: Vaginal Packing - RF and X-ray Detectable Folded
• 20884521701202: Vaginal Packing - RF and X-ray Detectable Folded
• 20884521701196: Vaginal Packing - RF and X-ray Detectable Roll
• 20884521701189: Vaginal Packing - RF and X-ray Detectable Folded
• 20884521701172: Vaginal Packing - RF and X-ray Detectable Roll
• 20884521701158: Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
• 20884521701141: Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
• 20884521701134: Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
• 20884521701127: Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
• 20884521701110: Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
• 20884521701103: Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
• 20884521701097: Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
• 20884521701080: Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
• 20884521701073: Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
• 20884521701042: OR Towel - RF and X-ray Detectable White
• 20884521701035: OR Towel -RF and X-ray Detectable Blue
• 20884521701028: Perineal Packing - RF and X-ray Detectable Roll
• 20884521701011: Perineal Packing - RF and X-ray Detectable Roll
• 20884521701004: Laparotomy Sponge - RF and X-ray Detectable Pre-washed
• 20884521700991: Laparotomy Sponge - RF and X-ray Detectable Pre-washed