AccessGUDID - DEVICE: Stephens Instruments (00810799033352)

GUDID

Device Identifier (DI) Information

Brand Name: Stephens Instruments
Version or Model: S5-1035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S5-1035
Company Name: KRISHNA IMPORTS INC

Primary DI Number: 00810799033352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081853285 *Terms of Use

Device Description: Desmarres Chalazion Forceps, 20x30mm

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
HNR	Forceps, ophthalmic

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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0184a2ff-72d1-4cad-a4f4-e310696fa099
Public Version Date: May 07, 2024
Public Version Number: 3
DI Record Publish Date: September 22, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(859)259-4925
Email: info@stephensinst.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES