AccessGUDID - DEVICE: neoprobe (00841911100324)

GUDID

Device Identifier (DI) Information

Brand Name: neoprobe
Version or Model: NPE14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NPE14
Company Name: DEVICOR MEDICAL PRODUCTS, INC.

Primary DI Number: 00841911100324
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961832156 *Terms of Use

Device Description: 14 mm Collimator, Model 1013

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?
42256	Single-hole nuclear medicine system collimator, straight-bore	An individual hollow-bore cylinder made of a dense material, e.g., lead (Pb), tungsten (W) or titanium (Ti), used to ensure that only gamma ray activity directly in front of the collimator channel reaches the scintillation crystal of the imaging or detector system. This GMDN code includes collimators designed to image low, medium or high-energy photons. It can be an integrated component of a hand-held probe, a detector array, or other kind of detector or imaging system, and includes interchangeable designs. It has attachment mechanisms enabling it to be safely transported, removed from, or attached to the detector head of a detector or imaging system.	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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 74cacb01-4f98-47df-9f77-162126fc0709
Public Version Date: May 13, 2025
Public Version Number: 3
DI Record Publish Date: November 10, 2016

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: Yes
Serial Number: No
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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