AccessGUDID - DEVICE: Polycryl (00803878041638)

GUDID

Device Identifier (DI) Information

Brand Name: Polycryl
Version or Model: A5108
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AUROLAB

Primary DI Number: 00803878041638
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 677319965 *Terms of Use

Device Description: Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A5108 model consists of a 5/0 PGA suture of length 45cm attached with two 330 microns SS needles having the needle length of 8.0mm in both the ends of suture. Angle of curvature of both the needles are 90° [1/4 Circle]. Point profile of both needles are Spatula.

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):	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?
38000	Nylon suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140039	000

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
Handling Environment Temperature: between 2 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a6cfed5-0ebd-4a3d-88ab-7f03a6c25670
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: December 12, 2020