FDA.reportPublic FDA data

Surgilon

Primary DI
10884521080454
Brand
Surgilon
Company
Covidien LP
Model
XX-5100
Device description
Braided Nylon
Published
2015-09-03
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
GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981582000SURGILON, DERMALON, & OPHTHALONDavis & Geck, Inc.1998-07-13GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521080451PackageGS136Not in Commercial Distribution
10884521080454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452108045120884521080451
1088452108045410884521080454

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length18Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052516SharpointSurgical Specialties México, S. de R.L. de C.V.GAR2026-08-26
10705031089020ETHILONETHICON, LLCGAR2026-08-25
10705031096479ETHILONETHICON, LLCGAR2026-08-25
00816848022964SUPRAMIDS JACKSON INCGAR2026-08-21
00816848022988SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023008SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023329SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023343SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023367SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023381SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023527SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023541SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023664SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023688SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023787SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023800SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023824SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023848SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023862SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023886SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023947SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023954SUPRAMIDS JACKSON INCGAR2026-08-21
00816848024029SUPRAMIDS JACKSON INCGAR2026-08-21
08903837402325TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
08903837799326TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
10705031245587ETHILONETHICON, LLCGAR2026-08-17
10705031245624ETHILONETHICON, LLCGAR2026-08-17
10705031465374ETHILONETHICON, LLCGAR2026-08-17
10705031465381ETHILONETHICON, LLCGAR2026-08-17
10705031465404ETHILONETHICON, LLCGAR2026-08-17