FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9196141000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD919614100
Catalog number
SD919614100
Device description
8 2/3" Micro-Laryngeal Alligator Kleinsasser Forceps with Irrigation, Heart-Shaped Jaws, Curved Left
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAEForceps, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9196141000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267926Snowden-PencerSTERIS Deutschland GmbHKAE2026-09-25
00724995271466V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995274955V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275013V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275020V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275037V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275044V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275051V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275068V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275075V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995330002V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
04046826110932MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-09-24
G141550875300Carnegie Surgical LLCCarnegie Surgical LLCKAE2026-09-19
00190776420413MillenniumAvalign Technologies, Inc.KAE2026-08-26
00190776420420MillenniumAvalign Technologies, Inc.KAE2026-08-26
04054462901692evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901708evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901715evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901722evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901739evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901746evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901760evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901807evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903160evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903177evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903184evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903191evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903207evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905591evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905607evonosevonos GmbH & Co. KGKAE2026-08-21