AccessGUDID - DEVICE: neoprobe (00841911102274)

GUDID

Device Identifier (DI) Information

Brand Name: neoprobe
Version or Model: NPCU4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DEVICOR MEDICAL PRODUCTS, INC.

Primary DI Number: 00841911102274
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961832156 *Terms of Use

Device Description: GDS Console, Model 2400

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40646	Hand-held-detector nuclear medicine system	An assembly of diagnostic devices comprising a hand-held, non-imaging system designed primarily to detect, record, quantify and analyse various radioactive emissions (gamma, alpha, beta) of injected or ingested radiopharmaceuticals, radiation emitting devices, or other materials. It is frequently used in the monitoring and detection of deep vein thrombosis (DVT), in surgical procedures requiring radionuclide localization and in some radiolabeled monoclonal antibody applications. It often has special software or accessory features that distinguish them from similar devices used for radiation protection purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZD	Probe, Uptake, Nuclear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6a74b6a-ae5b-484e-bd2d-5c86eba439a4
Public Version Date: May 21, 2019
Public Version Number: 1
DI Record Publish Date: May 13, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 877-926-2666
Email: customersupport@mammotome.com

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