FDA.reportPublic FDA data

Steelex

Primary DI
04038653911097
Brand
Steelex
Company
B BRAUN SURGICAL SA
Model
G0617814
Catalog number
G0617814
Device description
STEELEX STE SET 6 (8) 4X45CM HRS48
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
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
04046964272639PackageGS112Not in Commercial Distribution
04038653911097PrimaryGS10
04045439057368Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964272639040469642726394046964272639
04038653911097040386539110974038653911097
04045439057368040454390573684045439057368

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
Length45Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
511268005
Device count
12
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653915408SteelexC0992070C09920702015-08-16
04038653713929DafilonC0933350C09333502015-08-16
04046963634421PremileneC2090607C20906072015-08-17
04038653819362CatgutB0560570B05605702015-08-05
04038653822324CatgutB0563978B05639782015-11-01
04038653844357PremicronC0026016C00260162015-08-06
04046963462376PremicronB0026409B00264092015-11-05
04038653707621DagrofilC0840130C08401302015-08-16
04038653708567DagrofilC0842273C08422732015-08-16
04038653735068DagrofilG0341215G03412152015-08-20
04038653735105DagrofilG0341231G03412312015-08-20
04038653735181DagrofilG0341274G03412742015-08-20
04038653750337PremicronM0027706M00277062015-08-26
04038653750399PremicronM0027736M00277362015-08-26
04038653750436PremicronM0027756M00277562015-08-26
04038653750450PremicronM0027766M00277662015-08-26
04038653798865DagrofilC0346659C03466592015-08-13
04038653828104DagrofilB0842648B08426482015-11-01
04038653866960DagrofilC0852210C08522102015-08-16
04038653871230PremicronM0027776M00277762015-08-26

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Primary DI, Brand, Company table
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