FDA.report

Surgical Direct

Primary DI
B382SD50004S0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD500-04s
Catalog number
SD500-04s
Device description
Latex Free 10 ft Insufflation tubing, Small Direct Connector w .1 Micron Filter Sterile one time use,
Published
2022-11-30
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

Contact Domains

Product Codes

CodeName
NKCTubing/tubing with filter, insufflation, laparoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SD50004S0PrimaryHIBCC0

GMDN Terms

TermDefinition
Insufflation gas conditioning tubing setA collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags

DUNS number
124367223
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false
Sterilization required before use
false

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B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
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B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
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B382S2548020Surgical DirectS2548.02S2548.022026-03-09
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B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

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