AccessGUDID - DEVICE: MediChoice (10885632110344)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: FG1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632110344
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Forceps Adson Dressing Straight Single-Patient Use Stainless Steel 4.75 Inch Not Made With Natural Rubber Latex Sterile MediChoice

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":	Yes
For Single-Use:	Yes
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?
62489	Dressing/utility forceps, tweezers-like, single-use	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDC	INSTRUMENT, SURGICAL, DISPOSABLE

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify:
Special Storage Condition, Specify: Avoid Freezing and Excessive Heat
Handling Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8ac4c5b-931f-48cc-9941-50d0a7b71900
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: September 24, 2020