AccessGUDID - DEVICE: RAPIDLOC PDS PANACRYL (10886705010196)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDLOC PDS PANACRYL
Version or Model: 228311
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 228311
Company Name: DEPUY MITEK, LLC

Primary DI Number: 10886705010196
Issuing Agency: GS1
Commercial Distribution End Date: January 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 190572854 *Terms of Use

Device Description: RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 12 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and 12 Degrees curved needle

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):	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?
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDR	STAPLE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023388	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
Storage Environment Temperature: less than 26 Degrees Celsius
Storage Environment Temperature: less than 80 Degrees Fahrenheit
Handling Environment Temperature: less than 26 Degrees Celsius
Handling Environment Temperature: less than 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf261aa0-15f3-41fd-b804-9401a2128e8d
Public Version Date: January 28, 2021
Public Version Number: 7
DI Record Publish Date: September 01, 2015