FDA.reportPublic FDA data

HEARTLINE RETRACTOR BLADE

Primary DI
00192896093898
Brand
HEARTLINE RETRACTOR BLADE
Company
SONTEC INSTRUMENTS, INC.
Model
2800-807
Catalog number
2800-807
Device description
HEARTLINE RETRACTOR BLADE COOLEY TYPE BLADES
Published
2019-03-07
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
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896093898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896093898001928960938981928960938980192896093898

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular retractor, single-useA sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter

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
+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
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
00192896123533Rochester Carmalt Forceps1100-152LQ1100-152LQ2026-06-24
00192896123540Green Retractor207-298207-2982026-06-24
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
00192896038110SONTEC-MICHELE TREPHINE419-392419-3922018-09-11
00192896038127SONTEC-MICHELE TREPHINE419-393419-3932018-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD77550140Surgical DirectSurgical Direct, Inc.FFO2026-07-14
B382SD918174150Surgical DirectSurgical Direct, Inc.FFO2026-07-13