Mammotome Revolve EX Holster CA000609001

GUDID 00841911102861

Holster for ultrasound guided procedures

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system
Primary Device ID00841911102861
NIH Device Record Key43aa4d28-e77b-4c5b-91c4-523790539f62
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome Revolve EX Holster
Version Model NumberMHEXH1
Catalog NumberCA000609001
Company DUNS961832156
Company NameDEVICOR MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911102861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-26
Device Publish Date2025-09-18

Devices Manufactured by DEVICOR MEDICAL PRODUCTS, INC.

00841911102861 - Mammotome Revolve EX Holster2025-09-26Holster for ultrasound guided procedures
00841911102861 - Mammotome Revolve EX Holster2025-09-26 Holster for ultrasound guided procedures
00841911102335 - Mammotome Revolve EX2025-09-05 Revolve EX Ultrasound Holster - CE
10841911102349 - Mammotome Revolve EX2025-09-05 Revolve EX Ultrasound Probe with Sleeve - System Registered- CE
10841911102356 - Mammotome Revolve2025-09-05 Revolve EX Ultrasound 8G Probe without Sleeve - CE
00841911102366 - Mammotome Revolve EX2025-09-05 Revolve EX Ultrasound Holster Holder - CE
10841911102509 - Mammotome Revolve EX2025-09-05 Revolve EX Ultrasound Probe with Sleeve - CD
00841911103615 - Neoprobe2025-08-05 Bluetooth Angled Probe, Model 1106
00841911103622 - Neoprobe2025-08-05 Bluetooth Straight Probe - CE

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