AccessGUDID - DEVICE: PINHOLE Collimator (00850816007140)

GUDID

Device Identifier (DI) Information

Brand Name: PINHOLE Collimator
Version or Model: PINHOLE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DIGIRAD CORPORATION

Primary DI Number: 00850816007140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148548738 *Terms of Use

Device Description: No description.

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?
42257	Single-hole nuclear medicine system collimator, pinhole	A conical shaped housing of lead or equivalent material with a single small opening of a fixed diameter at the tapered end of the cone. It projects an inverted image of photon distribution onto the system's crystal detector ensuring that only gamma ray activity directly in front of the collimator channel reaches the scintillation crystal of the imaging or detector system. The shape of its base is intended to conform to the crystal shape of the nuclear medicine imaging system. Typically interchangeable, it is designed with attachment mechanisms that enable it to be safely transported, removed from, or attached to the detector head of the system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYX	Camera, Scintillation (Gamma)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee0fa363-029b-4bd9-b5bf-87638712ee4f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 12, 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8587261600
Email: callcenter@digirad.com

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