AccessGUDID - DEVICE: UROLIFT (10814932020138)

GUDID

Device Identifier (DI) Information

Brand Name: UROLIFT
Version or Model: IPN056133
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UL2-H
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10814932020138
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: UroLift 2 Delivery Handle, U.S.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
58882	Prostatic retraction implant	A sterile implantable device intended to increase prostatic urethral patency, and thereby relieve lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH), by physically compressing the prostate gland by retraction. The implant is in the form of a two orthogonal tags (e.g., metal) held together by a suture (e.g., monofilament), and is introduced so that one tag is outside the prostatic capsule and the other is in the urethra, with the suture providing retraction. It is not intended to be explanted. The device is implanted using a dedicated, single-use, hand-held, pistol-like delivery device through the sheath of a rigid endoscope.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PEW	Implantable transprostatic tissue retractor system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201837	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e12c367-64cd-4181-a70b-4af75a98ce88
Public Version Date: September 23, 2020
Public Version Number: 1
DI Record Publish Date: September 15, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20814932020135	2	10814932020138		In Commercial Distribution	Carton

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

Customer Contact

[?]

Phone: +1(925)401-0700
Email: uroliftcustomer@teleflex.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES