AccessGUDID - DEVICE: T'Lift® (03700393301360)

GUDID

Device Identifier (DI) Information

Brand Name: T'Lift®
Version or Model: AW16280
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AW16280
Company Name: PETERS SURGICAL

Primary DI Number: 03700393301360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 265741780 *Terms of Use

Device Description: Single use, laparoscopic retraction system

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?
61079	Externally-anchored laparoscopic retraction thread	A sterile surgical device intended to be used during a laparoscopic procedure to provide hands-free retraction (through suspension) of lower abdominal, urogenital and pelvic structures, and synthetic tissues. It is a length of thread (i.e., suture-like) with a needle attached at one end and toggle at the other, intended to be introduced into the surgical cavity and manipulated typically using laparoscopic grasping forceps. Typically it is intended to be threaded through obstructive tissues, held in place by the toggle, and exit the abdominal wall to be externally anchored, allowing for transabdominal suspension of structures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWV	Laparoscopic Accessories, Gynecologic

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: 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: 72f81a58-ca81-435d-bcab-69714727fb5a
Public Version Date: July 12, 2023
Public Version Number: 5
DI Record Publish Date: September 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
03700393301421	5	03700393301360	In Commercial Distribution	Box
03700393301414	12	03700393301360	In Commercial Distribution	Box
03700393301353	25	03700393301360	In Commercial Distribution	Box

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: +1 508-747-6033
Email: e.knupp@peters-surgical.com

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