AccessGUDID - DEVICE: David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare), refurb. (10697660002207)

GUDID

Device Identifier (DI) Information

Brand Name: David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare), refurb.
Version or Model: 21-322R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Oculo-Plastik Inc

Primary DI Number: 10697660002207
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 easy-to-use David-Baker Retractors feature a simple, curved clamping mechanism to gently retract the upper eyelid while protecting sensitive scleral membranes.

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?
32775	Eyelid clamp, reusable	A hand-held manual surgical instrument designed specifically to atraumatically grasp and hold the eyelid or isolate a portion of eyelid tissue during an ophthalmic surgical intervention (e.g., chalazion surgery, blepharostoplasty). It includes an appropriate clamping mechanism which may be one of a variety of designs (e.g., ring and disk), and may be referred to as entropion forceps, Downes lid clamp, or chalazion clamp. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDJ	Clamp, Surgical, General & Plastic Surgery

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
Width: 24 Millimeter

Device Record Status

Public Device Record Key: 072519db-90a3-40f8-8a4d-52e8d0f0b5e7
Public Version Date: December 08, 2022
Public Version Number: 3
DI Record Publish Date: November 18, 2019