FDA.report

HERCULES BANDAGE/PLASTER SHEARS

Primary DI
00192896026902
Brand
HERCULES BANDAGE/PLASTER SHEARS
Company
SONTEC INSTRUMENTS, INC.
Model
240-620
Catalog number
240-620
Device description
HERCULES BANDAGE/PLASTER SHEARS SERRATED BLADE
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
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896026902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896026902001928960269021928960269020192896026902

GMDN Terms

TermDefinition
Cast cutting shearsA large, scissors-like, hand-held instrument whose blades distal to the pivot point terminate in various jaw configurations, capable of cutting heavy layers of plaster or synthetic material used to form hardened casts, i.e., that which has already been used to form a cast around a patient's limb or body part. The tip of one of the distal blades forming the scissors-like cutting mechanism is usually rounded along it bottom edge to prevent injury to the patient as the cast is cut. This device is typically made of high-grade stainless steel and will usually be provided with a spring mechanism to assist in opening the jaws. This is a reusable device.

Device Sizes

TypeValueUnit
Length8Inch

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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