FDA UDI
In Commercial Distribution
🇺🇸 United States
T'Lift®
DI: 03700393301360
·
Model: AW16280
·
PETERS SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- T'Lift®
- Primary DI
- 03700393301360
- Version / Model
- AW16280
- Catalog Number
- AW16280
- Company Name
- PETERS SURGICAL
- Labeler DUNS
- 265741780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 5
- Public Version Date
- 2023-07-12
- Public Version Status
- Update
- Public Device Record Key
- 72f81a58-ca81-435d-bcab-69714727fb5a
Device Description
Single use, laparoscopic retraction system
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | 884.1720 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700393301421 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 03700393301360 | GS1 | ||||
| Package | 03700393301414 | GS1 | Box | 12 | In Commercial Distribution | |
| Package | 03700393301353 | GS1 | Box | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 508-747-6033
- [email protected]