FDA.reportPublic FDA data

Biopsy Punch

Primary DI
00192896123380
Brand
Biopsy Punch
Company
SONTEC INSTRUMENTS, INC.
Model
2901-117L
Catalog number
2901-117L
Device description
Biopsy Punch With Thorn Single Action Jaws
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102921000ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIESBema-GmbH & Co. KG2011-12-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896123380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896123380001928961233801928961233800192896123380

GMDN Terms#

Term, Definition table
TermDefinition
Skin-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically metallic and is available in various cutting head sizes; it is not a biopsy gun. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length450Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
040729840
Device count
1
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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