FDA.reportPublic FDA data

Proficient Surgical

Primary DI
16975424198729
Brand
Proficient Surgical
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
PS2037
Device description
INTRAOPERATIVE PROBE DRAPE, 5” X 96"
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222460000Intraoperative Ultrasound Probe CoverExact Medical Manufacturing2023-05-12ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975424198729PackageGS120In Commercial Distribution
26975424198726PackageGS160In Commercial Distribution
06975424198722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697542419872916975424198729
2697542419872626975424198726
06975424198722069754241987226975424198722

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative ultrasound imaging transducer coverA sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014464314
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975424190771Exact Medical Manufacturing, Inc.CS1000CS10002026-07-16
06975085709480Exact Medical Manufacturing, Inc.CS1000CS10002024-07-12
06975424199361Exact Medical Manufacturing, Inc.DEF5941DEF59412026-05-20
06975424199378Exact Medical Manufacturing, Inc.DEF5942DEF59422026-05-20
06975424199385Exact Medical Manufacturing, Inc.DEF5943DEF59432026-05-20
06975424199392Exact Medical Manufacturing, Inc.DEF5944DEF59442026-05-20
06975424199408Exact Medical Manufacturing, Inc.DEF5945DEF59452026-05-20
06975424199415Exact Medical Manufacturing, Inc.DEF5946DEF59462026-05-20
06975424199422Exact Medical Manufacturing, Inc.DEF5947DEF59472026-05-20
06975424199354Exact Medical Manufacturing, Inc.DEF5940DEF59402026-05-19
06975424199750Exact Medical Manufacturing, Inc.EN-RF-002EN-RF-0022026-05-19
06975424198722Proficient SurgicalPS20372026-03-11
06975424198739Proficient SurgicalPS89462026-03-11
16975424198736Proficient SurgicalPS89462026-03-11
06975424198838Exact Medical Manufacturing, Inc.VPS-G4SC-S1VPS-G4SC-S12026-03-09
06975424199279Exact Medical Manufacturing, Inc.E6997E69972026-03-09
26975424198832Exact Medical Manufacturing, Inc.VPS-G4SC-S1VPS-G4SC-S12026-03-09
16975424199276Exact Medical Manufacturing, Inc.E6997E69972026-03-09
06975424198449Exact Medical Manufacturing, Inc.TMPH-2000TMPH-20002025-11-19
06975424198456Exact Medical Manufacturing, Inc.TMPH-2002TMPH-20022025-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16