FDA.report

Surgical Direct

Primary DI
B382SD127690
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD12769
Catalog number
SD12769
Device description
Suction Irrigation Pistol Grip Handle
Published
2020-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SD127690PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical irrigation/aspiration systemAn assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B382S1350010Surgical DirectS1350.01S1350.012026-03-09
B382S18382020Surgical DirectS1838.202S1838.2022026-03-09
B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
B382S18382050Surgical DirectS1838.205S1838.2052026-03-09
B382S18382060Surgical DirectS1838.206S1838.2062026-03-09
B382S18382100Surgical DirectS1838.210S1838.2102026-03-09
B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
B382S2511200Surgical DirectS2511.20S2511.202026-03-09
B382S2548010Surgical DirectS2548.01S2548.012026-03-09
B382S2548020Surgical DirectS2548.02S2548.022026-03-09
B382S2871200Surgical DirectS2871.20S2871.202026-03-09
B382S344901020Surgical DirectS34490.102S34490.1022026-03-09
B382S3797050Surgical DirectS3797.05S3797.052026-03-09
B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00653405014952POOLEConmed CorporationGCX2026-03-24
50198956355475CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
50198956417999CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
G8057116571Bleed IDAPARATA MEDICAL, LLCGCX2026-03-02
50198956375640CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
50198956277937CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
20889483228743Muc-Away™SUNMED, LLCGCX2025-12-31
20889483228750Muc-Away™SUNMED, LLCGCX2025-12-31
20889483230111Muc-Away™SUNMED, LLCGCX2025-12-31
10889483230121Muc-Away™SUNMED, LLCGCX2025-12-31
50198956261806CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
50192253043363CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043370CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043387CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043394CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043400CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043417CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50198956252125CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
20816286021189Boehringer Surgical Suction DeviceBOEHRINGER LABORATORIES, LLCGCX2025-11-24
50198956160857CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
50198956180381CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
00194613008253MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019945MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019952MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021504MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021511MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021627MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021634MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021641MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021665MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01