AccessGUDID - DEVICE: Skytron (10841736122621)

GUDID

Device Identifier (DI) Information

Brand Name: Skytron
Version or Model: 5-010-09-4B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5-010-09-4B
Company Name: SKYTRON LLC

Primary DI Number: 10841736122621
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: 3/8 Inch X-RAY FT/LEG SECT. 3500/6500

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):	No
Over the Counter (OTC):	Yes
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?
36606	Fluoroscopy/angiography table top	A component of a modular operating table designed as a detachable table top constructed for use during surgical procedures requiring fluoroscopic guidance, such as cardiovascular surgery and other interventional radiology procedures (e.g., biopsy). This table top is typically a one-piece, and completely flat construction with an x-ray translucent section(s) providing x-rays free of artefacts. It is not dedicated to breast biopsy, and not designed to position a patient during other specialist surgeries (i.e., it is not a specialist operating table top with x-ray transparent features).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQO	TABLE, OPERATING-ROOM, AC-POWERED

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 Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef8ee8c9-3263-4964-8ac2-b45617fc75f9
Public Version Date: February 07, 2022
Public Version Number: 1
DI Record Publish Date: January 29, 2022

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800) 759-8766
Email: info@skytron.us

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