MANI Sutures Nylon 0550S

GUDID 04546951401115

MANI Ophthalmic Sutures

MANI, INC.

Nylon suture, non-bioabsorbable, monofilament

Primary Device ID	04546951401115
NIH Device Record Key	3da1e81a-8d2f-43e8-8efd-c20672394544
Commercial Distribution Status	In Commercial Distribution
Brand Name	MANI Sutures Nylon
Version Model Number	0550S
Catalog Number	0550S
Company DUNS	690622428
Company Name	MANI, 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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04546951401115 [Primary]
GS1	14546951401112 [Package] Package: [12 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K053637

FDA Product Code

GAR	Suture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-07
Device Publish Date	2016-06-04

On-Brand Devices [MANI Sutures Nylon]

04546951500375	7
04546951500344	40
04546951500320	39
04546951500313	38
04546951500290	36
04546951500283	35
04546951500269	33
04546951500252	32
04546951500245	31
04546951500153	23
04546951500139	21
04546951500108	19
04546951500092	18
04546951500078	16
04546951500061	15
04546951500047	13
04546951500030	12
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