AccessGUDID - DEVICE: Intacs Pocketing Hook (00850048576063)

GUDID

Device Identifier (DI) Information

Brand Name: Intacs Pocketing Hook
Version or Model: KV10606
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADDITION TECHNOLOGY, INC.

Primary DI Number: 00850048576063
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118496814 *Terms of Use

Device Description: Designed to be used in an operating room environment by a surgeon to delaminate cornea stroma to initiate a pocket on each side of the incision.

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?
13120	Ophthalmic surgical probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNG	Rongeur, Lachrymal Sac

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
No Device Sizes

Device Record Status

Public Device Record Key: 7243e9d2-5c8c-4372-920c-18dee043ae1d
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023