FDA.reportPublic FDA data

Ballenger Swivel Knife

Primary DI
00192896113770
Brand
Ballenger Swivel Knife
Company
SONTEC INSTRUMENTS, INC.
Model
467-5313
Device description
Ballenger Swivel Knife Bayonet
Published
2022-09-15
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
KASKNIFE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KASKnife, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896113770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896113770001928961137701928961137700192896113770

GMDN Terms#

Term, Definition table
TermDefinition
Nasal knifeA hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length8.75Inch

Sterilization Methods#

Method table
Method
"[""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
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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
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00724995267803Snowden-PencerSTERIS Deutschland GmbHKAS2026-09-25
00724995331443V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331481V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331498V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331504V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331511V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331528V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331535V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331610V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00724995331627V. MuellerSTERIS Deutschland GmbHKAS2026-09-25
00190776422622MillenniumAvalign Technologies, Inc.KAS2026-08-03
09348811143594INKAThe Trustee for KAISER FAMILY TRUSTKAS2026-03-18
09348811155153INKAThe Trustee for KAISER FAMILY TRUSTKAS2025-11-28
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00810207783176Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783183Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783190Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783206Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783213Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783220Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783237Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783244Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783251Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00190776414238MillenniumAvalign Technologies, Inc.KAS2025-10-22
00194613047528MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2025-08-01
04049047120292GimmiGimmi GmbHKAS2025-05-21
04049047120339GimmiGimmi GmbHKAS2025-05-21