FDA.report

DESCHAMPS LIGATURE CARRIER

Primary DI
00192896099050
Brand
DESCHAMPS LIGATURE CARRIER
Company
SONTEC INSTRUMENTS, INC.
Model
134-280M
Catalog number
134-280M
Device description
DESCHAMPS LIGATURE CARRIER LEFT HANDED MEDIUM SIZE BLUNT TIP
Published
2019-09-09
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
HCFInstrument, Ligature Passing And Knot Tying

Product Code Classifications

CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896099050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896099050001928960990501928960990500192896099050

GMDN Terms

TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Device Sizes

TypeValueUnit
Length8Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
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
true
Sterilization required before use
true

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00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
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