Steelex

Basic Information

• Brand Name: Steelex
• Primary DI: 04038653911097
• Version / Model: G0617814
• Catalog Number: G0617814
• Company Name: B BRAUN SURGICAL SA
• Labeler DUNS: 511268005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2015-08-20
• Public Version: 9
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: 19561d16-d2d0-46d9-a29c-6219d92133c0

Device Description

STEELEX STE SET 6 (8) 4X45CM HRS48

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: No
• 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
GAQ	SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE	General, Plastic Surgery	878.4495	2
PTX	Suture, nonabsorbable, steel, monofilament and multifilament, sterile, exempt	General, Plastic Surgery	878.4495	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15971	Metallic suture, monofilament	A single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04046964272639	GS1	Carton	12	In Commercial Distribution
Primary	04038653911097	GS1
Unit of Use	04045439057368	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	45	Centimeter
Device Size Text, specify			Thread Material : stainless steel
Device Size Text, specify			Size of Thread (USP - Others) : 6