FDA.reportPublic FDA data

Black Ceramitic Kerrison Punch Rongeur

Primary DI
00192896105690
Brand
Black Ceramitic Kerrison Punch Rongeur
Company
SONTEC INSTRUMENTS, INC.
Model
16-2102B
Device description
Black Ceramitic Kerrison Punch Rongeur 90 Degrees Up
Published
2020-11-24
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
HTXRONGEUR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896105690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896105690001928961056901928961056900192896105690

GMDN Terms#

Term, Definition table
TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length4Inch

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam 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
00192896045736TURNER WARWICK UROLOGICAL RETRACTOR516-8042-SET516-8042-SET2018-09-17
00192896123946Micro Osteotome475-7864475-78642026-10-27
00192896123953Laparoscopic Bulldog Clamp2901-281-452901-281-452026-10-27
00192896123960Laparoscopic Bulldog Clamp2901-281-602901-281-602026-10-27
00192896123977Yankauer Pediatric Suction Tube180-446180-4462026-10-27
00192896123984Trepsat Flap Dissecting Forceps438-635G438-635G2026-10-27
00192896123991Trepsat Flap Dissecting Forceps438-636G438-636G2026-10-27
00192896124004Trepsat Flap Dissecting Forceps438-637G438-637G2026-10-27
00192896124011Debakey Beck Clamp2100-7872100-7872026-10-27
00192896124028Debakey Beck Clamp2100-7882100-7882026-10-27
00192896040885Antrum Grasping Forceps468-360468-3602018-09-10
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09

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B382SD9212021100Surgical DirectSurgical Direct, Inc.HTX2022-12-01
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