Sutralene - 10-0 Suture USP / Thread Specifications: - VISIONARY MEDICAL SUPPLIES INC

Duns Number:111585795

Device Description: 10-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) 10-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 8 inch (20 cm) / Needle Specifications: TP-90-6, Taper Point, ¼ circle (90 degrees), length 13 mm, wire 0.15 mm / # of needles: Double arm

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More Product Details

Catalog Number

-

Brand Name

Sutralene

Version/Model Number

P109062TP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070243,K070243,K070243

Product Code Details

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Device Record Status

Public Device Record Key

3e4464cf-0553-489d-a5e0-6f6e085bcd87

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

June 14, 2016

Additional Identifiers

Package DI Number

M583P109062TP3

Quantity per Package

12

Contains DI Package

M583P109062TP2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"VISIONARY MEDICAL SUPPLIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 35