FDA.reportPublic FDA data

Endo Retract

Primary DI
10884523000849
Brand
Endo Retract
Company
Covidien LP
Model
176613
Device description
Fan Retractor
Published
2018-08-10
Public version status
Update
Distribution status
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914190000AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTORUnited States Surgical, A Division of Tyco Healthc1992-05-06GAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884523000846PackageGS16In Commercial Distribution
10884523000849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452300084620884523000846
1088452300084910884523000849

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, single-useA sterile, hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10Millimeter

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
10884521740150LigaSureMRASILF192026-10-01
10884521833098SharkCoreL-19-052026-10-01
10884521159754Nellcor100830582016-09-24
10884521850859Hugo RASMRASC00012026-01-09
10884521850880Hugo RASMRASC00022026-01-09
10884521780170INVOSPMAC71DOC2019-07-31
10884521186033LigaSureLF1212A2016-09-24
10884521744189LigaSureLF1212A2018-05-09
20884521186030LigaSureLF1212A2017-01-06
10884521032903BiosynGMT-2262015-09-01
10884521102163Vascufil88864788-05V2015-08-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433086MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433116MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433154MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433161MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776432959MillenniumAvalign Technologies, Inc.GAD2026-09-30
00190776432997MillenniumAvalign Technologies, Inc.GAD2026-09-30
G1415180500Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141518555120Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141528202010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572105820Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572106810Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572108210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157211460Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157212010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157213040Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
00190776432874MillenniumAvalign Technologies, Inc.GAD2026-09-29
00190776432515MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432591MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432621MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432638MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432669MillenniumAvalign Technologies, Inc.GAD2026-09-28
00840329838829N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329838980N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839000N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839017N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24