AccessGUDID - DEVICE: 20GA Non-Adjustable Membrane Scraper (00632307000027)

GUDID

Device Identifier (DI) Information

Brand Name: 20GA Non-Adjustable Membrane Scraper
Version or Model: PD800.20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Peregrine Surgical, Llc

Primary DI Number: 00632307000027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622467348 *Terms of Use

Device Description: 20GA Non-Adjustable Membrane Scraper

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):	Yes
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?
47364	General-purpose ophthalmic hook, single-use	A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 Gauge Needle
Needle Gauge: 20 Gauge

Device Record Status

Public Device Record Key: 5f4f97ba-1e53-4a54-8724-be9a20380688
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: May 06, 2016