AccessGUDID - DEVICE: RapidEase™ (00191083047683)

GUDID

Device Identifier (DI) Information

Brand Name: RapidEase™
Version or Model: 4561SC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4561SC
Company Name: Rti Surgical, Inc.

Primary DI Number: 00191083047683
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117560455 *Terms of Use

Device Description: Single Strand Pre-Sutured Tendon

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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60501	Tendon graft	A sterile tendon tissue, which may include a bone block, intended for transplantation that is harvested from a human donor. The tissue is intended to be used to replace or strengthen damaged tendon in any part of the human body. It may include non-tissue components (e.g. suture) to facilitate its implantation or function. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAT	Suture, nonabsorbable, synthetic, polyethylene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230036	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Frozen (-40C(-40F) or less to exp)

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Folded Diameter: 8.5-12mm Length: 180-220mm

Device Record Status

Public Device Record Key: f80886e1-e11b-464f-9e8c-86df2c7e23f2
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 03, 2023

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: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

Phone: +1(386)418-8888
Email: labeling@rtix.com

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