AccessGUDID - DEVICE: ACHILLON® (10381780043300)

GUDID

Device Identifier (DI) Information

Brand Name: ACHILLON®
Version or Model: 119720ND
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 119720ND
Company Name: NEWDEAL

Primary DI Number: 10381780043300
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2027
Device Count: 3
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The needle for the Achillon® suture system is used to suture the Achilles tendon parts in acute Achilles tendon rupture.

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?
61143	Suturing needle, single-use	A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCF	INSTRUMENT, LIGATURE PASSING AND KNOT TYING

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: a256f998-558b-4dd3-ac63-607cf57066b4
Public Version Date: February 06, 2023
Public Version Number: 6
DI Record Publish Date: October 05, 2017