AccessGUDID - DEVICE: Instrapac (05010058088139)

GUDID

Device Identifier (DI) Information

Brand Name: Instrapac
Version or Model: 8813
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8813
Company Name: ROBINSON HEALTHCARE LIMITED

Primary DI Number: 05010058088139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 237799775 *Terms of Use

Device Description: Instrapac Plastic Forceps 13cm x 100

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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
HTD	FORCEPS

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry and keep out of sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 13 Centimeter

Device Record Status

Public Device Record Key: a16b97f9-9373-444d-9280-aa601234952b
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: August 12, 2022