FDA.reportPublic FDA data

St. Marks Hand Retractor

Primary DI
00192896109841
Brand
St. Marks Hand Retractor
Company
SONTEC INSTRUMENTS, INC.
Model
508-326SL
Catalog number
508-326SL
Device description
St. Marks Hand Retractor With Lip Illuminated
Published
2021-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDGRetractor, Fiberoptic
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896109841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896109841001928961098411928961098410192896109841

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length9Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27
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00192896123762TAVR Removal Set2400-200-SET2400-200-SET2026-09-18
00192896123779Waever Chalazion Forceps14-988014-98802026-09-18
00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
00192896123632Adson Dressing Forceps140-299S140-299S2026-08-27
00192896123649Converse Scissors460-156L460-156L2026-08-27
00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
00192896123663Meyerding Finger Retractor205-856Q205-856Q2026-08-27
00192896123670Meyerding Finger Retractor205-857Q205-857Q2026-08-27
00192896122499Cartilage Graft Cutter350-842350-8422025-11-21
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur Shaft404-312B404-312B2026-08-25
00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD91471781500Surgical DirectSurgical Direct, Inc.FGN2026-07-27
B382SD9141051110Surgical DirectSurgical Direct, Inc.FGN2026-07-24
B382SD155310120Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD155310140Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD1553600Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD9070791100Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD9073531010Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD90738400T0Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD9073931130Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD974411110Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B803NL97020450ORTHOMEDORTHO-MED, INC.FGN2026-06-25
B803COD5045680ORTHOMEDORTHO-MED, INC.FGN2026-06-23
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B803COD5045710ORTHOMEDORTHO-MED, INC.FGN2026-06-23
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B803MA1108360ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1108370ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020100ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020110ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020120ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020130ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020140ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020150ORTHOMEDORTHO-MED, INC.FGN2026-06-23