FDA.report

ANDERSON BEAR CLAW HOOK RETRACTOR

Primary DI
00192896042445
Brand
ANDERSON BEAR CLAW HOOK RETRACTOR
Company
SONTEC INSTRUMENTS, INC.
Model
475-535
Catalog number
475-535
Device description
ANDERSON BEAR CLAW HOOK RETRACTOR SHARP PRONGS
Published
2018-09-13
Public version status
New
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
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY
KALRetractor, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896042445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896042445001928960424451928960424450192896042445

GMDN Terms

TermDefinition
Skin/tissue hookA hand-held manual surgical instrument designed to hook skin or tissue in order to grasp, apply traction, and lift the skin/tissue during a surgical intervention. It is typically a shaft-like instrument with small double hooks at the distal end and a handle at the proximal end. The hooks are curved in opposite directions and when the device is placed onto the skin or tissue to be grasped, it is twisted clockwise so that the hooks lock into the skin/tissue. Also known as a tissue pick, it is not unlike a hooked wound retractor. It is made of high-grade stainless steel and may be supplied with a cylindrical steel protecting sheath for storage and sterilization. This is a reusable device.

Device Sizes

TypeValueUnit
Length5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat 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

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