FDA.reportPublic FDA data

Surgitie

Primary DI
20884521099460
Brand
Surgitie
Company
Covidien LP
Model
SGL-3
Device description
Ligating Loop with Delivery System
Published
2015-09-02
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
GALSUTURE, ABSORBABLE, NATURAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904588000AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOPUnited States Surgical, A Division of Tyco Healthc1990-12-24GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521099460PackageGS112In Commercial Distribution
10884521099463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452109946020884521099460
1088452109946310884521099463

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic ligature loopA device that is used to constrict a protruding tissue, e.g., a varix or a polyp to prevent or control bleeding following, e.g., a polypectomy, thereby creating a haemostasis or necrosis during an endoscopic procedure. It is applied using a dedicated endoscopic ligator. This is a single-use device.

Device Sizes#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
false
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
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
00848782052455SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-08-26
00840118621410Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621427Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621434Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621441Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00814639026962Premium UNIFY Fast Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026979Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026993Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027006Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027013Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027020Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027037Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027044Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027051Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06