V.A.T.S. MAYO HEGAR NEEDLE HOLDER

GUDID B099230090410

V.A.T.S. MAYO HEGAR NEEDLE HOLDER WITH RATCHET TUNGSTEN CARBIDE SERRATED STRAIGHT

SONTEC INSTRUMENTS, INC.

Needle holder, reusable

Primary Device ID	B099230090410
NIH Device Record Key	4dfcf9ed-3513-463b-b7ce-1e04b12ee67e
Commercial Distribution Status	In Commercial Distribution
Brand Name	V.A.T.S. MAYO HEGAR NEEDLE HOLDER
Version Model Number	2300-9041
Company DUNS	040729840
Company Name	SONTEC INSTRUMENTS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	13 Inch
Length	13 Inch
Length	13 Inch
Length	13 Inch
Length	13 Inch
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch
Length	13 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	13 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896004375 [Primary]
HIBCC	B099230090410 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152400

FDA Product Code

GCJ	Laparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099230090410]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099230090410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-09-28
Device Publish Date	2018-08-28

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