FDA.reportPublic FDA data

Steel

Primary DI
10884521102422
Brand
Steel
Company
Covidien LP
Model
88862345-53
Device description
Monofilament Stainless Steel
Published
2015-08-31
Public version status
Update
Distribution status
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955723000STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)Davis & Geck, Inc.1996-02-27GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521102429PackageGS112In Commercial Distribution
10884521102422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452110242920884521102429
1088452110242210884521102422

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
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
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
00643169694859TrailBlazer™AngledASC-014-0902016-10-22
00643169694866TrailBlazer™AngledASC-014-1352016-10-22
00643169694873TrailBlazer™AngledASC-014-1502016-10-22
00643169694880TrailBlazer™AngledASC-018-0902016-10-22
00643169694897TrailBlazer™AngledASC-018-1352016-10-22
00643169694903TrailBlazer™AngledASC-018-1502016-10-22
00643169694910TrailBlazer™AngledASC-035-0652016-10-22
00643169694927TrailBlazer™AngledASC-035-0902016-10-22
00643169694934TrailBlazer™AngledASC-035-1352016-10-22
00643169694941TrailBlazer™AngledASC-035-1502016-10-22
00763000004804TrailBlazer™ AngledASC-014-0902017-12-22
00763000004811TrailBlazer™ AngledASC-014-1352017-12-22
00763000004828TrailBlazer™ AngledASC-014-1502017-12-22
00763000004835TrailBlazer™ AngledASC-018-0902017-12-22
00763000004842TrailBlazer™ AngledASC-018-1352017-12-22
00763000004859TrailBlazer™ AngledASC-018-1502017-12-22
00763000004866TrailBlazer™ AngledASC-035-0652017-12-22
00763000004873TrailBlazer™ AngledASC-035-0902017-12-22
00763000004880TrailBlazer™ AngledASC-035-1352017-12-22
00763000004897TrailBlazer™ AngledASC-035-1502017-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10652927785309DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786085DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786092DemeSTEELDemetech CorporationGAQ2023-08-22
10652927777823DemeSTEELDemetech CorporationGAQ2022-12-21
10652927782926DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783176DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783183DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783190DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783206DemeSTEELDemetech CorporationGAQ2022-12-21
10652927722694DemeSTEELDemetech CorporationGAQ2020-10-13
10652927697220DemeSTEELDemetech CorporationGAQ2020-01-15
10652927669869DemeSTEELDemetech CorporationGAQ2019-12-24
10652927669876DemeSTEELDemetech CorporationGAQ2019-12-24
10652927684169DemeSTEELDemetech CorporationGAQ2019-12-24
10652927151050DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161042DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161172DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164265DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164371DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165026DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165033DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165576DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174226DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174233DemeSTEELDemetech CorporationGAQ2019-07-11
10652927176909DemeSTEELDemetech CorporationGAQ2019-07-11
10652927207382DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216797DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216841DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219736DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219743DemeSTEELDemetech CorporationGAQ2019-07-11