FDA.reportPublic FDA data

T'Lift®

Primary DI
03700393301421
Brand
T'Lift®
Company
PETERS SURGICAL
Model
AW16280
Catalog number
AW16280
Device description
Single use, laparoscopic retraction system
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700393301353PackageGS125In Commercial Distribution
03700393301414PackageGS112In Commercial Distribution
03700393301421PackageGS15In Commercial Distribution
03700393301360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700393301353037003933013533700393301353
03700393301414037003933014143700393301414
03700393301421037003933014213700393301421
03700393301360037003933013603700393301360

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retraction threadA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33470584170vectec@vectec.fr
+1 508-747-6033e.knupp@peters-surgical.com

Regulatory Flags#

DUNS number
265741780
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661522011782CARDIOXYL ®73S15B2020-01-04
03661522011805CARDIOXYL ®73P30A2020-01-04
03661522011812CARDIOXYL ®73P30B2020-01-04
03661522011829CARDIOXYL ®73P30D2020-01-04
03661522011836CARDIOXYL ®73P30E2020-01-04
03661522011843CARDIOXYL ®73P30F2020-01-04
03661522011850CARDIOXYL ®73P30G2020-01-04
03661522011867CARDIOXYL ®73P30I2020-01-04
03661522011874CARDIOXYL ®73P30J2020-01-04
03661522011881CARDIOXYL ®73P30K2020-01-04
03661522011898CARDIOXYL ®73P30L2020-01-04
03661522011904CARDIOXYL ®73P30O2020-01-04
03661522011911CARDIOXYL ®73P30P2020-01-04
03661522011928CARDIOXYL ®73P30Q2020-01-04
03661522011935CARDIOXYL ®73P30R2020-01-04
03661522011942CARDIOXYL ®73P30S2020-01-04
03661522011959CARDIOXYL ®73P30T2020-01-04
03661522011966CARDIOXYL ®73S15C2020-01-04
03661522011973CARDIOXYL ®73S20A2020-01-04
03661522011980CARDIOXYL ®73S20B2020-01-04

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