FDA.report

LAPAROSCOPE FIXATION HOLDER

Primary DI
B09928901500
Brand
LAPAROSCOPE FIXATION HOLDER
Company
SONTEC INSTRUMENTS, INC.
Model
28901-50
Device description
FIXATION LAPAROSCOPE HOLDER WITH FLEXIBLE SNAKE ARM
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B09928901500PrimaryHIBCC0

GMDN Terms

TermDefinition
Laparoscopic mechanical-distention systemAn assembly of mechanical devices intended to be used to create a space in the abdominal cavity for laparoscopic procedures by externally lifting the abdominal wall. This isobaric method of lifting the abdominal wall includes the insertion of a retractor, sling, subcutaneous wires or needles and an external lifting mechanism consisting of, e.g., a manual traction device, a support arm clamped to the operating table, or a winch and framework. This device requires no, or minimal, gas insufflation. This is a reusable device.

Device Sizes

TypeValueUnit
Height28Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8008217496INFO@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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