Exact Medical Manufacturing ProbeCoverPolyurethane-L-1

GUDID 16975424191515

Probe Cover Polyurethane

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 16975424191515
• NIH Device Record Key: c1643704-16f8-4c95-8612-27ca1fd99b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Medical Manufacturing
• Version Model Number: ProbeCoverPolyurethane-L-1
• Catalog Number: ProbeCoverPolyurethane-L-1
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424191518 [Primary]
GS1	16975424191515 [Package]; Contains: 06975424191518; Package: Inner Case [30 Units]; In Commercial Distribution
GS1	26975424191512 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211969

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [Exact Medical Manufacturing]

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• 00852205007946: Microscope Drape, Leica 137x381cm – 54” x 150”
• 00852205007915: EP5512
• 00850015378294: Probe Cover, 14 x 29.2, Kit, VIP Film w/ Elastic Bands & EMM Gel
• 00850015378539: Surgical Gown, Large, AAMI 4 HaloGuard
• 00850024023017: C-Arm Drape 107x165cm
• 00850033380606: Sheet 140cmx140cm Kit Pack Fold
• 00850033380583: Sheet 140cmx140cm Fan Fold
• 00850033380569: Sheet 120cmx120cm Kit Pack Fold
• 00850033380545: Sheet 120cmx120cm Fan Fold
• 00850033380521: Sheet 90cmx90cm Kit Pack Fold
• 00850033380507: Sheet 90cmx90cm Fan Fold
• 00850033380620: Micromate Needle Guide Set/Device Cover PE w Needle Guide 8G-11G Elastic Band 35x110cm
• 00850033380675: Femoral Drape 220x380cm
• 00850033380651: Reinforced BTC
• 00850033380712: Robot Drape
• 00850033380743: Screen Cover with cuff 34x76cm
• 00850033380767: Dome Bag 18cm - 7"
• 00850033380781: C-Arm Drape with Clips 41x230cm - 16"x91"
• 00850033380811: Drape, PU, 60x60cm round fen 6cm with Adhesive
• 00816953024358: C-Arm Drape 224X107cm - 88"x42"
• 00850033380842: Probe Cover, VIP film, Gel, Elastic bands 15x91cm - 6"x36"
• 10850033380887: Sponge Counter Bag Rack
• 00850037124008: Drape 90x90cm, Fenestration 10cm round ADH, Bi-Laminate
• 00850037124022: C-Arm Kit XLVI (46)
• 06975085709206: Micromate Tracker and Drape
• 16975085708534: Micromate Needle Guide Set/Device Cover PE w Needle Guide 8G-11G Elastic Band 35x110cm
• 16975085708817: Probe Cover, PE, Gel and Elastic bands, 6"x96"
• 16975085708503: Drape for VITOM® eagle (TH201)
• 26975085708357: Surgical Gown, X-Large, Fabric Reinf. AAMI 3
• 26975085708340: Surgical Gown, Large, Fabric Reinf. AAMI 3
• 16975085706103: Sterile Drape CCU 25cm wide x 100cm long
• 16975085706073: Device Cover PE w Needle Guide 11G-14G Elastic Band 35x110cm
• 16975085706066: Device Cover PE w Needle Guide 15G-21G Elastic Band 35x110cm
• 16975424191515: Probe Cover Polyurethane
• 16975424191508: Probe Cover Polyurethane
• 16975085703744: EXPLORER AIR® Sterile Drape
• 16975424193359: Probe Cover, VIP film, Gel & Elastic bands 15x122cm-6"x48"
• 16975424193342: Probe Cover, PE, Gel and Elastic bands 15x122cm, 6"x48"
• 16975424194554: Micromate Control Unit Drape
• 16975424194547: Micromate Needle Guide 8-11G
• 16975424194530: Micromate Needle Guide 15-21G
• 16975424194523: Micromate Needle Guide 10-14G
• 26975424194612: Hemorrhage View C-Section Drape, sterile
• 16975424195285: Foot Switch Cover with drawstring 36x76cm - 14"x30"
• 26975424195251: Hemorrhage View C-Section Drape,Sterile, full incision panel
• 26975424195237: Hemorrhage View C-Section Drape, Sterile, Pear Shaped fenestration within incision panel
• 16975424195391: Remote Control Cover 125x260mm