FDA.reportPublic FDA data

Exact Medical Manufacturing, Inc.

Primary DI
06975424198449
Brand
Exact Medical Manufacturing, Inc.
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
TMPH-2000
Catalog number
TMPH-2000
Device description
UNIVERSAL GAMMA PROBE CVR 1.25in. x 12in. (3cm x30.5cm)
Published
2025-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
16975424198446PackageGS110In Commercial Distribution
26975424198443PackageGS1200In Commercial Distribution
06975424198449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697542419844616975424198446
2697542419844326975424198443
06975424198449069754241984496975424198449

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
014464314
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
16975424198729Proficient SurgicalPS20372026-03-11
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
06975424198456Exact Medical Manufacturing, Inc.TMPH-2002TMPH-20022025-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
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00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01