FDA.report

ENDOLARYNGEAL MICRO HOOK

Primary DI
00192896058729
Brand
ENDOLARYNGEAL MICRO HOOK
Company
SONTEC INSTRUMENTS, INC.
Model
1301-525
Catalog number
1301-525
Device description
ENDOLARYNGEAL MICRO HOOK ANGLED BLUNT TIP
Published
2018-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896058729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896058729001928960587291928960587290192896058729

GMDN Terms

TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct) to allow surgical intervention on those tissues. It is not primarily designed for pulling aside tissues for surgical access purposes (i.e., not a retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length10Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10
00192896122734Metzenbaum Scissors1200-5211200-5212026-03-10
00192896122741Micro Alligator Forceps469-017469-0172026-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417970MillenniumAvalign Technologies, Inc.LRC2026-03-23
00198506089756ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-23
00198506089657ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-17
00198506089534ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089541ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089558ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089572ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904428798377OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00198506088926ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-03
00190776417420MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417475MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417482MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417543MillenniumAvalign Technologies, Inc.LRC2026-02-27
00198506088865ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-25
00198506088469ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00198506088544ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00190776416546MillenniumAvalign Technologies, Inc.LRC2026-02-16
00190776415914MillenniumAvalign Technologies, Inc.LRC2026-02-06
00190776415778MillenniumAvalign Technologies, Inc.LRC2026-02-04
04059453133779Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-02-02
00198506088346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-30
04059453133755Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-01-29
09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
00190776415495MillenniumAvalign Technologies, Inc.LRC2026-01-27
00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16
00198506087899ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15
00198506087912ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15
00198506087929ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15