AccessGUDID - DEVICE: Amsco (00724995155018)

GUDID

Device Identifier (DI) Information

Brand Name: Amsco
Version or Model: 3080-R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RC3
Company Name: STERIS CORPORATION

Primary DI Number: 00724995155018
Issuing Agency: GS1
Commercial Distribution End Date: July 03, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The 3080-R Remanufactured Table is a general operating table that can handle a variety of surgical specialties including urology, neurology, pediatrics, ENT and endovascular procedures.

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?
33152	Universal operating table, electromechanical	A mobile, electrically-powered motorized table designed to be adjusted to support a patient during many types of surgical interventions. The table surface may consist of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or designed to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWW	TABLE, OPERATING-ROOM, PNEUMATIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930493	000

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: fa96fb94-c5fa-485e-ba6e-6f15bcda1f5d
Public Version Date: July 04, 2023
Public Version Number: 2
DI Record Publish Date: August 05, 2021