FDA.reportPublic FDA data

TURNER WARWICK UNIVERSAL RETRACTOR BLADE

Primary DI
00192896080737
Brand
TURNER WARWICK UNIVERSAL RETRACTOR BLADE
Company
SONTEC INSTRUMENTS, INC.
Model
516-802BK
Catalog number
516-802BK
Device description
TURNER WARWICK UNIVERSAL RETRACTOR BLADE WITH CLIP FLAT BLADE #K STAINLESS STEEL
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896080737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896080737001928960807371928960807370192896080737

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842102116421Bookler Table Mounted Retractor SystemsFLEXBAR MACHINE CORPORATIONFFO2026-03-19
09348811023667INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-03-16
00192896122765Balfour Deluxe RetractorSONTEC INSTRUMENTS, INC.FFO2026-03-10
B382SD4942000Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942010Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942020Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942030Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942040Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942050Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942060Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942070Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942080Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942090Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942100Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942110Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942120Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942130Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942140Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942150Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942160Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942170Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942180Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942190Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942200Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942210Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494222Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494223Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942240Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942250Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942260Surgical DirectSurgical Direct, Inc.FFO2026-03-02