AccessGUDID - DEVICE: Fomon Ball Stainless Steel Retractor for Laser (non glare) (10697660002177)

GUDID

Device Identifier (DI) Information

Brand Name: Fomon Ball Stainless Steel Retractor for Laser (non glare)
Version or Model: 21-319
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Oculo-Plastik Inc

Primary DI Number: 10697660002177
Issuing Agency: GS1
Commercial Distribution End Date: March 24, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 257382580 *Terms of Use

Device Description: The Fomon Ball is a retractor with two curved rods and two tiny spheres. All non-reflective.

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):	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?
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 1e3216c7-f8cd-4010-a2e9-bcbf32013ad9
Public Version Date: March 25, 2022
Public Version Number: 2
DI Record Publish Date: November 15, 2019