FDA Registration Active 🇺🇸 United States

Polyglycolytic Acid Absorbable Sutr

Reg #: 3011137372 · FEI: 3005747797 · Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1

Registration Details

Registration Name
Teleflex Medical LLC
Registration Number
3011137372
FEI Number
3005747797
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
3015 Carrington Mill Blvd
City
Morrisville
State
NC
ZIP
27560
Country
US

Regulatory Submissions

510(k) Number
K060801

Owner / Operator

Firm Name
Teleflex
Operator Number
9062981
Address
3015 Carrington Mill Blvd.
City
Morrisville
State
NC
Postal Code
27560
Country
US
Correspondent
Divya Raman

Products

Device Name Product Code
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

Proprietary Names

Polyglycolytic Acid Absorbable Sutr Bondek Bondek Plus Deknatel

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility