FDA.reportPublic FDA data

Steelex

Primary DI
04038653910519
Brand
Steelex
Company
B BRAUN SURGICAL SA
Model
G0617792
Catalog number
G0617792
Device description
STEELEX STE SET4(6)4X45CMHRS48 AX(M)LPCE
Published
2015-08-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
PTXSuture, nonabsorbable, steel, monofilament and multifilament, sterile, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2
PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653910519PrimaryGS10
04045439057320Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653910519040386539105194038653910519
04045439057320040454390573204045439057320

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
511268005
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653911097SteelexG0617814G06178142015-08-20
04038653906703SteelexG0617741G06177412015-08-20
04038653910113SteelexG0617733G06177332015-08-20
04038653910120SteelexG0617750G06177502015-08-20
04038653910137SteelexG0617717G06177172015-08-20
04038653910144SteelexG0617776G06177762015-08-20
04038653910502SteelexG0617784G06177842015-08-20
04038653913527SteelexG0617742G06177422015-08-20
04038653916405SteelexG0617795G06177952015-08-20
04045439016747SteelexG0617802G06178022015-08-20
04046963374280SteelexG0617135G06171352015-08-20
04046963374310SteelexG0617134G06171342015-08-20
04038653741502SilkamG0760412G07604122015-08-20
04038653741526SilkamG0760420G07604202015-08-20
04038653741601SilkamG0760480G07604802015-08-20
04038653741700SilkamG0760986G07609862015-08-20
04038653741786SilkamG0762040G07620402015-08-20
04038653741816SilkamG0762067G07620672015-08-20
04038653741830SilkamG0762075G07620752015-08-20
04038653741854SilkamG0762083G07620832015-08-20

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