FDA Registration Active 🇺🇸 United States

ULTRABRAID #2 WHITE 38 LENGTH, SINGLE

Reg #: 1643264 · FEI: 1643264 · Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1

Registration Details

Registration Name
SMITH & NEPHEW INC.
Registration Number
1643264
FEI Number
1643264
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
ENDOSCOPY, 76 S. MERIDIAN AVE.
City
OKLAHOMA CITY
State
OK
ZIP
73107
Country
US

Regulatory Submissions

510(k) Number
K041216

Owner / Operator

Firm Name
Smith & Nephew, Inc.
Operator Number
1020279
Address
2875 Railroad Street
City
Pittsburgh
State
PA
Postal Code
15222
Country
US
Correspondent
Lisa Ewing

Products

Device Name Product Code
Suture, Nonabsorbable, Synthetic, Polyethylene GAT

Proprietary Names

ULTRABRAID #2 WHITE 38 LENGTH, SINGLE ULTRABRAID No.2 COBRAID SUTURE AND NEEDLE ASSEMBLY, 38 INCH, STERILE MENISCAL ROOT REPAIR PACK WITH ULTRABRAID ULTRABRAID ULTRABRAID 2-0 CO-BRAID WHITE/BLUE SUTURE AND NEEDLES, 24 INCHES. 10 PACK ULTRABRAID #2 WHITE 38" LENGTH; Two UltraBraid Sutures (#2) ULTRABRAID 2-0 COBRAID 24 10 PACK ULTRABRAID No.2 WHITE SUTURE AND NEEDLE ASSEMBLY, 38 INCH, STERILE ULTRABRAID 2 COBRAID 38 LENGTH SINGL ULTRABRAID 2-0 WHITE 24 W/NEED 10 PACK ULTRABRAID 2-0 WHITE 24 10 PACK SUTURE, #2 CO-BRAID, ULTRABRAID, 38" SUTURE, #2, BLUE/WHITE,COBRAID 34 SUTURE, #2 WHITE, ULTRABRAID, 38"

Establishment Types

Manufacture Medical Device